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Ovarian NeoplasmsPhase 2NCT02736305

Use of Regorafenib in Recurrent Epithelial Ovarian Cancer

A Phase 2 study testing Regorafenib in people with Ovarian Neoplasms, run by National Cancer Centre, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1 Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR). Read more about this study

Who is it for?
Ages 21 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Neoplasms
What is being tested?
Regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteSingapore
Study dates
3 Feb 2016to 18 Nov 2019
Phase
Phase 2
Are there results?
None posted in the registry

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 21 to 99 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.
  • Patients with histologically and/or cytologically confirmed epithelial ovarian carcinoma (serous, clear cell, endometrioid, mucinous, mixed, carcinosarcoma and others), fallopian tube and primary peritoneal carcinoma.
  • Progressive disease following 2 or more prior cytotoxic chemotherapy. Patients may have received prior treatment with bevacizumab.
  • Age ≥ 21 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy greater than 3 months
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  • Measurable disease by RECIST 1.1 OR non measurable but evaluable disease such as ascites and pleural effusions attributable to disease or radiologic abnormalities that did not meet RECIST criteria AND a pre-treatment serum Ca-125 level greater than or equal to 2 times the upper limit of normal on 2 occasions at least 1 week apart OR pre treatment Ca-125 level greater or equal to 2 times the upper limit of normal on 2 occasions at least 1 week apart and non evaluable, non measurable disease.
  • Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and haemoglobin (Hb) > 9 g/dl. Blood transfusion to meet the inclusion criteria will not be allowed.
  • Adequate liver function as assess by: total bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5.0 x ULN if liver metastases are present.
  • Adequate renal function as assessed by serum creatinine ≤ 1.5 x ULN and glomerular filtration rate (GFR) ≥ 30 ml/min according to Cockcroft-Gault formula.
  • Systolic blood pressure ≤ 160 mmHg.
  • Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care.
  • International normalized ratio (INR) ≤ 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant e.g. heparin will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists.

Who cannot join

  • Patients who are receiving any other investigational agents.
  • Previous assignment to treatment during this study. Subjects permanently withdrawn from study treatment participation will not be allowed to re-enter the study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition used in the study.
  • Prior treatment with regorafenib.
  • Previous or concurrent cancer that is distinct in primary site of histology from EOC within the last 5 years EXCEPT for curatively treated cervical cancer in situ, non melanoma skin cancer and superficial bladder tumours [Ta (non invasive tumour), Tis (carcinoma in situ) and T1 (tumour invades lamina propria)].
  • Patients with known brain metastases.
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  • Uncontrolled inter-current illness including, but not limited to, on going or active infection (> Grade 2 NCI CTCAE v 4.00), symptomatic congestive heart failure (≥ New York Heart Association (NYHA) class 2), unstable angina pectoris, new onset angina (begun within the last 3 months), myocardial infarction less than 6 months before, cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), pre existing poorly controlled hypertension (systolic blood pressure > 160mmHg or diastolic pressure > 90 mmHg despite optimal medical management), history of abdominal fistula, history of gastrointestinal perforation and signs or symptoms of bowel obstruction.
  • Subjects with phaeochromocytoma.
  • Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risk or compromise compliance with the protocol.
  • Patients unable to swallow orally administered medication and patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of either study drug (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome).
  • Patients who have undergone major surgery, open biopsy of significant traumatic injury ≤ 28 days prior to starting study drug.
  • Patient with bowel resection within the past 1 year.
  • Patients with a past history of bowel perforation and abdominal fistula; patients with a recent history of bowel resection (within the past 12 months) and/or patients with symptoms of radiological evidence of active bowel obstruction.
  • Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. Patients must have recovered from all therapy related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
  • Patients with venous thromboembolism disease or pulmonary embolism within 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication).
  • Arterial thrombotic event including transient ischaemic attack (TIA), cerebrovascular accident (CVA) and peripheral arterial embolus within the last 6 months before start of study medication.
  • Subjects with evidence or history of any bleeding diathesis irrespective of severity.
  • Non-healing wound, ulcer or bone fracture.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Subjects with seizure disorder requiring medication.
  • History of organ allograft.
  • Renal failure requiring haemo- or peritoneal dialysis.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • Interstitial lung disease with on-going signs and symptoms at the time of informed consent.
  • Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy and hormonal therapy during this trial or within 4 weeks (or 6 weeks for nitrosurea, antibodies or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy.
  • Pregnant or breast-feeding in females. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
  • Inability to attend or comply with treatment of follow-up scheduling.
  • Persistent proteinuria > 3.5g/24 hours measured by urine protein-creatinine ratio from a random urine sample
  • Any haemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication
  • Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: An Open-Label, Single-Arm Phase 2 Clinical Trial Of Regorafenib in Patients With Multiply Recurrent Epithelial Ovarian Cancer

Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1 Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR). Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone in the management of ovarian cancer both as part of frontline adjuvant treatment and as second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been FDA approved for the treatment of patients with metastatic colorectal cancer who have failed prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.

Read the detailed description

STUDY OBJECTIVES

The objective of this study is to evaluate the efficacy and safety of regorafenib at a dose of 120mg daily for 21 days out of every 28 day cycle in Asian females with multiply recurrent EOC.

Primary Endpoint:

Investigator assessed progression free survival (PFS)

Secondary Endpoints:

Being tested
Regorafenib
Keywords
ovarian, regorafenib, platinum resistant, clear cell, endometrioid
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • RegorafenibDrug

    Also called Stivarga

    Once a day for 21 days in a 28 days cycle

Study groups in NCT02736305
Study groupRoleWhat they receive
RegorafenibExperimentalPatients will receive Regorafenib 120mg once daily, with consideration for dose escalation to 160mg if there are no toxicities
Receives: Drug: Regorafenib

What is being measured

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

  1. Investigator assessed progression free survival (PFS)

    Measured: 30 days after the last dose of regorafenib

Secondary outcomes (3)

  1. Overall survival (OS)

    Measured: 30 days after the last dose of regorafenib

  2. Overall tumour response rate (ORR) as per Gynecological Cancer Intergroup (GCIG) and RECIST v1.1 criteria

    Measured: 30 days after the last dose of regorafenib

  3. Treatment Emergent Adverse Events

    During the study period, patients will undergo evaluations for safety and drug tolerability.

    • Unexpected and expected toxicities including Hand Foot Syndrome, Liver dysfunction, Hypertension, Bleeding, Nausea and Diarrhoea
    • Death

    Measured: 30 days after the last dose of regorafenib

Timeline

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

  1. First posted13 Apr 2016 (estimated)
  2. Study start3 Feb 2016
  3. Primary completion18 Nov 2019
  4. Study completion18 Nov 2019

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02736305
Sponsor's protocol ID
NCC OV-01
Status last verified
Jun 2022
First submitted
13 Oct 2015
Last updated
13 Jun 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib in people with Ovarian Neoplasms, run by National Cancer Centre, Singapore at 1 site in Singapore.

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 13 inclusion and 30 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: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Investigator assessed progression free survival (PFS) (time frame: 30 days after the last dose of regorafenib). 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 NCT02736305.

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 13 Jun 2022.

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