Status:
COMPLETED
A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)
Lead Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Collaborating Sponsors:
GOG Foundation
Conditions:
Recurrent Platinum Resistant Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.
Eligibility Criteria
Inclusion
- Female patients ≥18 years of age
- Histologically confirmed epithelial ovarian cancer and documented disease.
- Patients must have platinum-resistant disease
- Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
- ECOG PS 0-1.
- Adequate hematological functions:
- ANC ≥ 1000/mm3
- PLT ≥ 100,000/mm3
- PT and PTT (seconds) \< 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
- Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).
Exclusion
- Non-epithelial tumors (Carcino-sarcomas are excluded)
- Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
- History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
- Previous ovarian cancer treatment with \>5 anticancer regimens.
- Any prior radiotherapy to the pelvis or whole abdomen.
- Inadequate liver function, defined as serum creatinine \> ULN, unless calculated creatinine clearance \> 50ml/min (by Cockroft \& Gault formula):
- Serum (total) bilirubin \> ULN (Exception: documented Gilbert's disease patients can be enrolled)
- Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).
- Inadequate renal function, defined as:
- Serum creatinine \> ULN OR
- Calculated creatinine clearance \< 50ml/min (by Cockroft \& Gault formula)
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
- History of stroke or transient ischemic attack within 6 months prior to day of randomization.
- Patient with proliferative and/or vascular retinopathy
- Known brain metastases
- History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- History of abdominal fistula or gastrointestinal perforation.
- Current signs and symptoms of bowel obstruction
- Uncontrolled active infection
- Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT03398655
Start Date
December 19 2017
End Date
July 19 2022
Last Update
January 10 2023
Active Locations (94)
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1
UAB Division of GYN Oncology
Birmingham, Alabama, United States, 35344
2
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
3
Arizona Oncology Associates, PC - HAL - USO
Phoenix, Arizona, United States, 85016
4
Arizona Oncology Associates, PC - HAL - USO
Tempe, Arizona, United States, 85284