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Ovarian NeoplasmsPhase 2NCT04807166

Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer

A Phase 2 study testing Drug: Anlotinib and Drug: Carboplatin/Paclitaxel in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by Wenjun Cheng at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

It has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Drug: Anlotinib and Drug: Carboplatin/Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
6 sitesChina
Study dates
24 Aug 2021to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Subjects must be female ≥18 years old;
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1；
  • Postoperative administration time: within 12 weeks after the maximum tumor reduction operation;
  • Histologically or pathologically confirmed advanced (FIGO stage III - IV) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer；
  • Subjects have enough organ function: (1) Blood routine(without blood transfusion or hematopoietic stimulating factor within 7 days before screening ): a.Hemoglobin (HB)≥9.0g/L; b.Absolute value of neutrophil (ANC)≥1.5 * 10^9 / L; c.Platelet (PLT)≥80 * 10^9 / L; (2) Liver and Renal function(without blood or albumin transfusion within 7 days before screening ): a. Alanine aminotransferase (ALT) and AST≤2.5 times the upper limit of normal value and ALT (AST≤5 times the upper limit of normal value when liver/bone metastasis) b. total bilirubin ≤1.5 times the upper limit of normal value; c.serum creatinine ≤1.5 times the upper limit of normal value, creatinine clearance≥60 ml/min; (3)Blood coagulation function: a.Activated partial thromboplastin time, international standardized ratio adn prothrombin time ≤1.5 times the upper limit of normal value; b.Doppler echocardiographic evaluation: left ventricular ejection fraction(LVEF)≥ 50%
  • Subjects agreed to join the study and signed informed consent;

Who cannot join

  • 1. Previously received anti angiogenic drugs including but not limited to small molecules such as anlotinib and apatinib and large molecules such as bevacizumab.
  • 2. Patients allergic to the any test drug.
  • 3. Combined disease/ history:
  • Clinical significant hemoptysis occurred within 3 months before admission (daily hemoptysis was greater than 50ml), or significant clinical bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood or above, or suffering from vasculitis, etc;
  • Arteriovenous thrombosis events occurred within 6 months before grouping, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by venous catheterization due to early chemotherapy) and pulmonary embolism;
  • Hypertension, which can not be well controlled by antihypertensive drugs (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg); Myocardial infarction, severe / unstable angina pectoris, cardiac insufficiency above New York Heart Association(NYHA) , supraventricular or ventricular arrhythmias with clinical significance, and symptomatic congestive heart failure occurred within 6 months before grouping;
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  • Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g. diabetes, pulmonary fibrosis and acute pneumonia);
  • Renal insufficiency: urine routine indicates urinary protein ≥ + +, or confirms 24-hour urinary protein ≥ 1.0g;
  • History of live attenuated vaccine vaccination within 28 days before the first study medication or expected live attenuated vaccination during the study period;
  • Human immunodeficiency virus infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis;
  • There were severe infections within 4 weeks before the first administration, including, but not limited to, bacteremia and severe pneumonia requiring hospitalization; active infections requiring systemic antibiotics treatment of grade CTCAE ≥ 2 within 2 weeks before the first administration, or unexplained fever > 38.5 °C during the screening period / before the first administration (the researchers judged that fever caused by tumors could be included in the group); there was evidence of active tuberculosis infection within 1 year before administration;
  • Any other malignant tumor has been diagnosed within 3 years before enrollment, except for fully treated basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ;
  • Major surgery was performed within 28 days before enrollment (tissue biopsy required for diagnosis and central venous catheterization via peripheral venipuncture are allowed);
  • Subjects who have previously received or are prepared to receive allogeneic bone marrow transplantation or solid organ transplantation;
  • Patients with peripheral neuropathy ≥2 grade 2; patients with active brain metastasis, carcinomatous meningitis, spinal cord compression, or diseases found in brain or leptomeninges by imaging CT or MRI examination during screening (patients with brain metastasis who had completed treatment 14 days before admission and whose symptoms were stable can be enrolled in the group, but no symptoms of cerebral hemorrhage should be confirmed by cranial MRI, CT or venography)；
  • Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction with significant clinical significance
  • 4. Women of child-bearing potential should have negative results of serum or urine pregnancy test. Women must use adequate birth control in the duration of study participation.
  • 5. Other serious physical or mental disorders or laboratory abnormalities that may increase the risk when in this study or interfere with the results of the study, and patients whom the researchers believe are not suitable for this study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Huai'an First People's Hospital

    Huai'an

  • Nanjing Drum Tower Hospital

    Nanjing

  • Zhongda Hospital Southeast University

    Nanjing

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Affiliated Hospital of Jiangnan University

    Wuxi

  • Yancheng No.1 People's Hospital

    Yancheng

Other trials in China

About this study

Official title: A Prospective, Single-arm, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy and Safety of Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer

It has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Therefore, this study is expected to investigate the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer.

Read the detailed description

This study is a single-arm, multicenter, exploratory phase II study to observe the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer. The primary end point are progression free survival; the secondary end points include objective response rate, disease control rate, overall survival and safety. The subjects in this study: patients with newly diagnosed advanced (FIGO stage III-IV) ovarian cancer, including histologically or pathologically confirmed high-grade serous ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma

Being tested
Drug: Anlotinib, Drug: Carboplatin/Paclitaxel
Keywords
First-line treatment, Advanced Ovarian Cancer, Anlotinib, Carboplatin/Paclitaxel, Efficacy and Safety
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms by Site, Genital Neoplasms, Female, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Carcinoma, Ovarian Epithelial, Ovarian Diseases

What participants receive

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

  • Drug: AnlotinibDrug

    Also called FOCUS V

    Anlotinib will be administered orally,once a day (12 mg) on days 1-14 of a 21-day cycle

  • Drug: Carboplatin/PaclitaxelDrug

    Also called bobei， Lipusu

    Paclitaxel 175 mg/m2 was given intravenously for 3 hours, D1 Carboplatin AUC 5 was given intravenously for 1 hour, D1

Study groups in NCT04807166
Study groupRoleWhat they receive
Anlotinib Combined With Carboplatin/PaclitaxelExperimentalAnlotinib Combined With Carboplatin/Paclitaxel
Receives: Drug: Drug: Anlotinib; Drug: Drug: Carboplatin/Paclitaxel

What is being measured

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

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from the initial treatment to disease progression (defined by RECIST 1.1) or death of any cause

    Measured: Through study completion, an average of 1-2 year

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1

    Measured: Through study completion, an average of 1 year

  2. Disease Control Rate (DCR)

    Disease control rate is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.

    Measured: Through study completion, an average of 1 year

  3. Overall survival (OS)

    Overall survival (OS) is defined as time from randomisation to the first occurrence of death from any cause [ Time Frame: From date of treatment beginning until the date of death from any cause

    Measured: Through study completion, an average of 1 year

  4. Adverse events (AE)

    Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted19 Mar 2021
  2. Study start24 Aug 2021
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04807166
Sponsor's protocol ID
JiangsuCHENG001
Status last verified
Jun 2024
First submitted
15 Mar 2021
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Contact Prof. Cheng for primary data.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drug: Anlotinib and Drug: Carboplatin/Paclitaxel in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by Wenjun Cheng at 6 sites in China.

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 6 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression Free Survival (PFS) (time frame: Through study completion, an average of 1-2 year). 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 NCT04807166.

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 3 Jul 2024.

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