Fallopian Tube CancerPhase 2NCT01137071

Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

A Phase 2 study testing Monoclonal antibody Hu3S193 in people with Fallopian Tube Cancer and Ovarian Cancer, run by Recepta Biopharma at 8 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
What is being tested?: Monoclonal antibody Hu3S193
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 8 sitesBrazil
Study dates: Apr 2011to Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

The Informed Consent Form (ICF) must be signed before the performance of any study specific procedure or treatment.
Female patients of >= 18 years of age.
Relapsing ovarian adenocarcinoma, fallopian tubes or primary peritoneal who achieved a complete clinical response after the first treatment of relapse with platinum-based regimen. A complete response is defined as the absence of cancer related symptoms, normal physical exam, normal CA-125 (tumor marker) level, normal chest X-ray and CT-scan of abdomen/pelvis. Eligibility allows the presence of nonspecific findings as long as not showing clear evidence of disease such as: lymph node and/or soft tissue abnormalities <= 1.0 cm which are frequently present on the pelvis and will not be considered to be a conclusive evidence of disease.
Expression of antigen Ley documented by immunohistochemistry of archived primary or metastatic tumor samples.
The patient must have been submitted at least to hysterectomy and bilateral salpingo-oophorectomy before entering the study and must have received platinum-based chemotherapy as adjunctive or neo-adjunctive treatment at the first presentation.
At least 5 and no more than 8 cycles of platinum combination therapy (i.e. doublet) as treatment for the first relapse.

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All side effects from chemotherapy must have been resolved or must be grade 1.
Interval between the last dose of the treatment with platinum that achieved clinical CR (complete response) and the first dose of Hu3S193 =< 8 weeks.
Karnofsky performance status >= 70%.
Results of laboratorial exams in the first 2 weeks before drug infusion within the following values:
Absolute Neutrophil Count >= 1.5 x 10x3 / mm3
Platelet count >= 100 x 10x3 / mm3
Blood bilirubin <= 2.0 mg/dL
Aspartate aminotransaminase (AST) and Alanine aminotransferase (ALT) <= 2.5 x upper limit of normal (ULN).
Blood creatinine <= 2.0 mg/dL.
Prothrombin time < 1.3 x control
Expected survival >= 12 months.
Patients must be willing to participate and be able to comply with the protocol throughout the study.

Who cannot join

Mucinous or clear cell histology.
Patients must not have received Bevacizumab as part of their treatment on relapse.
Diagnosis of primary tumor relapse made exclusively based on elevated levels of serum CA-125 with values <2-fold the upper limit of normality.
Concomitant use of systemic corticosteroids or immunosuppressive agents.
Known CNS (central nervous system) involvement by tumor.
Clinically significant heart disease (New York Heart Association Class III or IV).

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ECG indicating clinically significant arrhythmia.
History of myocardial infarction within 6 months.
Other serious diseases, (e.g.: serious infections requiring antibiotics, bleeding disorders, chronic inflammatory bowel disease, or diseases that may interfere in the obtainment of accurate study results).
Radiotherapy treatment, radiopharmaceuticals (e.g. 32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy or surgery within 4 weeks before the first administration of investigational product fail to recover from toxic effects of any of these therapies within 6 weeks prior to study inclusion.
Exposure to any investigational product within 4 months prior to study inclusion.
Previous treatment with a humanized murine antibody and/or fragment of such antibody.
Previous history of tumor (excluding appropriately treated non-melanoma skin cancer or carcinoma in situ of the cervix or no evidence of disease within at least 5 years for previous breast cancer or stage I endometrial cancer).

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Brazil8 sites

Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-700
Cetus Hospital-Dia Oncologia Ltda - Filial Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-280
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
Fundação Amaral Carvalho
Jaú, São Paulo, 17210-080
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110
Instituto do Câncer do Estado de São Paulo "Octávio Frias de Oliveira"
São Paulo, São Paulo, 01246-000
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05651-901

Other trials in Brazil

About this study

Official title: A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response

PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

Read the detailed description

This is a phase II multicenter trial with Hu3S193 as a single agent in a consolidation strategy in patients with relapsing platinum-sensitive ovarian, primary peritoneal and fallopian tubes cancer who achieve a second Complete Response after a platinum-based chemotherapy after platinum-based chemotherapeutical regimen. Fifty-one (51) patients with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tubes adenocarcinoma will receive doses of 30 mg/m2 of Hu3S193 as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). After the treatment period, patients will be evaluated every 3 months for the first two years, and every 6 months for more 3 years, and then in an annual-basis until disease progression or death, whichever happens first.

Conditions: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Being tested: Monoclonal antibody Hu3S193
Medical subject headings: Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Monoclonal antibody Hu3S193Biological
30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.

Study groups in NCT01137071
Study group	Role	What they receive
Monoclonal antibody hu3S193	Experimental	Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks. Receives: Biological: Monoclonal antibody Hu3S193

What is being measured

The primary outcome is the main question the study is designed to answer.

1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy
PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.
Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
Measured: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.

Secondary outcomes (57)

1-year Disease Progression-free Survival Rate
Measured: 1 year from the beginning of platinum-based rescue chemotherapy start date
Two-year Overall Survival Rate
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Measured: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
Safety - Vital Signs - Heart Rate
Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.
Measured: Baseline, week 2 , week 4 and week 27
Safety - Vital Signs - Respiratory Rate
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Measured: Baseline, week 2, week 4 and week 27
Safety - Vital Signs - Systolic and Diastolic Blood Pressure
Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Measured: Baseline, week 2, week 4 and week 27
Safety - Vital Signs - Temperature
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Measured: Baseline, week 2, week 4 and week 27
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Nervous System Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Investigations
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Vascular Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)
The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Measured: From the first infusion of medication to 30 days after the last one
Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Measured: From the first infusion of medication to 30 days after the last one
Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)
Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.
Measured: Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9
Two-year Overall Survival: Median Time to Death
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Measured: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Jun 2015

First posted4 Jun 2010 (estimated)
Study startApr 2011
Primary completionJun 2015
Study completionJun 2015

Why it stopped: Total number of pts expected to be enrolled would not be met.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01137071
Sponsor's protocol ID: RCP-Ov-01.10
Status last verified: Jan 2017
First submitted: 31 May 2010
Last updated: 23 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Recepta Biopharma understands the importance of individual-patient data (IPD) sharing and will include it in its future clinical studies; however, as this clinical study initiated in Apr-2011, an IPD was not planned.

Publications

Smaletz O, Ismael G, Del Pilar Estevez-Diz M, Nascimento ILO, de Morais ALG, Cunha-Junior GF, Azevedo SJ, Alves VA, Moro AM, Yeda FP, Dos Santos ML, Majumder I, Hoffman EW. Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission. Int J Gynecol Cancer. 2021 Apr;31(4):562-568. doi: 10.1136/ijgc-2020-002239. Epub 2021 Mar 4.
PubMed 33664128

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma

All Fallopian Tube Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response
ClinicalTrials.gov ID: NCT01137071
Acronym / sponsor ID: RCP-Ov-01.10
Conditions: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Total number of pts expected to be enrolled would not be met.
Enrolment: 29 participants (actual)
Lead sponsor: Recepta BiopharmaIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 4 Jun 2010 (estimated)
Results: Posted 29 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Monoclonal antibody hu3S193	Experimental	Biological: Monoclonal antibody Hu3S193Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

The Informed Consent Form (ICF) must be signed before the performance of any study specific procedure or treatment.
Female patients of >= 18 years of age.
Relapsing ovarian adenocarcinoma, fallopian tubes or primary peritoneal who achieved a complete clinical response after the first treatment of relapse with platinum-based regimen. A complete response is defined as the absence of cancer related symptoms, normal physical exam, normal CA-125 (tumor marker) level, normal chest X-ray and CT-scan of abdomen/pelvis. Eligibility allows the presence of nonspecific findings as long as not showing clear evidence of disease such as: lymph node and/or soft tissue abnormalities <= 1.0 cm which are frequently present on the pelvis and will not be considered to be a conclusive evidence of disease.
Expression of antigen Ley documented by immunohistochemistry of archived primary or metastatic tumor samples.
The patient must have been submitted at least to hysterectomy and bilateral salpingo-oophorectomy before entering the study and must have received platinum-based chemotherapy as adjunctive or neo-adjunctive treatment at the first presentation.

Key exclusion criteria (13 listed)

Mucinous or clear cell histology.
Patients must not have received Bevacizumab as part of their treatment on relapse.
Diagnosis of primary tumor relapse made exclusively based on elevated levels of serum CA-125 with values <2-fold the upper limit of normality.
Concomitant use of systemic corticosteroids or immunosuppressive agents.
Known CNS (central nervous system) involvement by tumor.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Monoclonal antibody Hu3S19330 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.	Biological	Monoclonal antibody hu3S193

Primary outcome

1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy
Time frame: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.
PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.

57 secondary outcomes

1-year Disease Progression-free Survival Rate
Time frame: 1 year from the beginning of platinum-based rescue chemotherapy start date
Two-year Overall Survival Rate
Time frame: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
Safety - Vital Signs - Heart Rate
Time frame: Baseline, week 2 , week 4 and week 27
Safety - Vital Signs - Respiratory Rate
Time frame: Baseline, week 2, week 4 and week 27
Safety - Vital Signs - Systolic and Diastolic Blood Pressure
Time frame: Baseline, week 2, week 4 and week 27
Safety - Vital Signs - Temperature
Time frame: Baseline, week 2, week 4 and week 27
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Nervous System Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Investigations
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Vascular Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)
Time frame: From the first infusion of medication to 30 days after the last one
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)
Time frame: From the first infusion of medication to 30 days after the last one

Results and safety

Results posted to the registry on 29 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
hu3S193	29	15

Primary outcome: 1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy

Time frame: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.. Median (95% Confidence Interval). Unit: Months

Measure	hu3S193 n = 29
Value	11.7614 (10.5902 to 13.9251)

Population analysed: In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).

57 secondary outcomes are reported in the full results.

Adverse events

Time frame: They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
hu3S193	3 of 29 (10.3%)	28 of 29 (96.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33664128Smaletz O, Ismael G, Del Pilar Estevez-Diz M, Nascimento ILO, de Morais ALG, Cunha-Junior GF, Azevedo SJ, Alves VA, Moro AM, Yeda FP, Dos Santos ML, Majumder I, Hoffman EW. Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission. Int J Gynecol Cancer. 2021 Apr;31(4):562-568. doi: 10.1136/ijgc-2020-002239. Epub 2021 Mar 4.
Individual participant dataSharing planned: No. Recepta Biopharma understands the importance of individual-patient data (IPD) sharing and will include it in its future clinical studies; however, as this clinical study initiated in Apr-2011, an IPD was not planned.

Related trials for Fallopian Tube Cancer

RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oren Smaletz, MD study chair

Recepta Biopharma S.A.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Monoclonal antibody Hu3S193 in people with Fallopian Tube Cancer and Ovarian Cancer, run by Recepta Biopharma at 8 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy (time frame: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01137071, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.