Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Gynecologic Cancer
Enrollment Eligibility
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