Recurrent Platinum Resistant Ovarian Cancer
Conditions
Keywords
Recurrent Ovarian cancer, Platinum resistant ovarian cancer, Ovarian cancer, Ovarian carcinoma, Epithelial ovarian cancer, paclitaxel
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.
Interventions
DRUGVB-111 + Paclitaxel
VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Sponsors
GOG Foundation
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female patients ≥18 years of age 2. Histologically confirmed epithelial ovarian cancer and documented disease. 3. Patients must have platinum-resistant disease 4. Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment. 5. ECOG PS 0-1. 6. 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. 7. 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 criteria
1. Non-epithelial tumors (Carcino-sarcomas are excluded) 2. Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors. 3. 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. 4. Previous ovarian cancer treatment with \>5 anticancer regimens. 5. Any prior radiotherapy to the pelvis or whole abdomen. 6. 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). 7. Inadequate renal function, defined as: * Serum creatinine \> ULN OR * Calculated creatinine clearance \< 50ml/min (by Cockroft & Gault formula) 8. New York Heart Association (NYHA) Grade II or greater congestive heart failure 9. History of myocardial infarction or unstable angina within 6 months prior to day of randomization. 10. History of stroke or transient ischemic attack within 6 months prior to day of randomization. 11. Patient with proliferative and/or vascular retinopathy 12. Known brain metastases 13. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization 14. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). 15. History of abdominal fistula or gastrointestinal perforation. 16. Current signs and symptoms of bowel obstruction 17. Uncontrolled active infection 18. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | From randomization until death from any cause (up to 5 years after last study treatment) |
| Progression Free Survival (PFS) by RECIST 1.1 | From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment) |
Secondary
| Measure | Time frame |
|---|---|
| Combined CA-125 and RECIST 1.1 response (GCIG) | From date of study entry until the date of death from any cause, or up to 5 years after last study treatment |
| CA-125 Response (GCIG) | From date of study entry until the date of death from any cause, or up to 5 years after last study treatment |
| Objective response rate (ORR) by RECIST 1.1 | From date of study entry until the date of death from any cause, or up to 5 years after last study treatment |
| OS100 for a sensitivity analysis of OS | From 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment |
Countries
Israel, Japan, Poland, Spain, United States
Outcome results
None listed