Open Actively Recruiting
A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)
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.
- 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).
- 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
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