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

Description

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 plus paclitaxel to paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Study Start Date

December, 19 2017

Estimated Completion Date

June 2023

Interventions

  • Drug: Paclitaxel
  • Drug: VB-111 + Paclitaxel

Study ID

Vascular Biogenics Ltd. operating as VBL Therapeutics -- VB-111-701/GOG-3018

Status

Recruiting

Trial ID

NCT03398655

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

350

Sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

Inclusion Criteria

    1. Female patients ?18 years of age 2. Histologically confirmed epithelial ovarian cancer (mucinous adenocarcinoma, clear cell carcinomas and grade 1 serous tumors are excluded) 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 0-2. 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.

Exclusion Criteria

    1. Non-epithelial tumors (Carcino-sarcomas are excluded) 2. Ovarian tumors with low malignant potential (i.e. borderline tumors) and 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 >3 anticancer regimens. 5. Any prior radiotherapy to the pelvis or abdomen. 6. Inadequate liver function, defined as:
  • 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 and renal function 7. New York Heart Association (NYHA) Grade II or greater congestive heart failure 8. History of myocardial infarction or unstable angina within 6 months prior to day of randomization. 9. History of stroke or transient ischemic attack within 6 months prior to day of randomization. 10. Patient with proliferative and/or vascular retinopathy 11. Known brain metastases 12. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization 13. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). 14. History of abdominal fistula or gastrointestinal perforation. 15. Current signs and symptoms of bowel obstruction 16. Uncontrolled active infection

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Richard Penson MD None None

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