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

Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:December 19, 2017
End Date:June 2023

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A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

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.

Inclusion Criteria:

1. Female patients ≥18 years of age

2. Histologically confirmed epithelial ovarian cancer 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 0-1.

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.

7. Patients who are known to carry a BRCA mutation (following PARP inhibitor treatment
failure, intolerant of, or ineligible for PARP inhibitor treatment).

Exclusion Criteria:

1. Non-epithelial tumors (Carcino-sarcomas are excluded)

2. Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell
carcinomas, grade 1 serous tumors or 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 >5 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)

8. New York Heart Association (NYHA) Grade II or greater congestive heart failure

9. History of myocardial infarction or unstable angina within 6 months prior to day of

10. History of stroke or transient ischemic attack within 6 months prior to day of

11. Patient with proliferative and/or vascular retinopathy

12. Known brain metastases

13. History of hemoptysis or active GI bleeding within 6 month prior to day of

14. Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation).

15. History of abdominal fistula or gastrointestinal perforation.

16. Current signs and symptoms of bowel obstruction

17. Uncontrolled active infection
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Principal Investigator: Joyce Barlin, MD
Phone: 518-458-1390
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Principal Investigator: Michael Callahan, MD
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859) 257-9000
Principal Investigator: Frederick Ueland, MD
Phone: 859-323-3975
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