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

  • STATUS
    Recruiting
  • End date
    Jun 2, 2023
  • participants needed
    400
  • sponsor
    Vascular Biogenics Ltd. operating as VBL Therapeutics
Updated on 2 September 2021
Investigator
Shifra Fain-Shmueli
Primary Contact
National Defense Medical College Hospital (8.1 mi away) Contact
+90 other location

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.

Details
Condition Recurrent Platinum Resistant Ovarian Cancer
Treatment Paclitaxel, VB-111 + Paclitaxel, Placebo + Paclitaxel
Clinical Study IdentifierNCT03398655
SponsorVascular Biogenics Ltd. operating as VBL Therapeutics
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
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