Open Actively Recruiting

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


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.

Primary Purpose
Study Type
Phase III


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

  • 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 Criteria:

  • 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

Join this Trial

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Study Stats
Protocol No.
Obstetrics & Gynecology
Jenny Lester
  • UCLA Westwood
For Providers
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