A Study of VB-111 Combined 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 plus paclitaxel to paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.
Study Start Date
December, 19 2017
Estimated Completion Date
- Drug: Paclitaxel
- Drug: VB-111 + Paclitaxel
Vascular Biogenics Ltd. operating as VBL Therapeutics -- VB-111-701/GOG-3018
Vascular Biogenics Ltd. operating as VBL Therapeutics
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
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.
1. Non-epithelial tumors (Carcino-sarcomas are excluded)
2. Ovarian tumors with low malignant potential (i.e. borderline tumors) and mucinous
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
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Massachusetts General Hospital - Boston, Massachusetts||2.8 miles||Richard Penson MD||None||None|