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



Status:Recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
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
randomization.

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

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
randomization

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
We found this trial at
9
sites
801 North 29th Street
Billings, Montana 59107
406-238-2500
Principal Investigator: Benjamin Marchello, MD
Phone: 406-696-3488
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Richard Penson, MD
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Albany, New York 12208
Principal Investigator: Joyce Barlin, MD
Phone: 518-458-1390
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Greenville, South Carolina 29615
Principal Investigator: Jeffrey Elder, MD
Phone: 864-242-2762
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Haifa, 31096
Principal Investigator: Amnon Amit, MD
Phone: 972-4-7771796
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Indianapolis, Indiana 46260
Principal Investigator: Michael Callahan, MD
Phone: 317-415-6747
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Frederick Ueland, MD
Phone: 859-323-3975
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Lisa Barroilhet, MD
Phone: 608-263-2079
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Morristown, New Jersey 07960
Principal Investigator: Nana Tchabo, MD
Phone: 973-971-6608
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Morristown, NJ
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