Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
Krishnansu Tewari, MD

Description

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.

Official Title

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

Keywords

Recurrent Platinum Resistant Ovarian Cancer Recurrent Ovarian cancer Platinum resistant ovarian cancer Ovarian cancer Ovarian carcinoma Epithelial ovarian cancer paclitaxel Ovarian Neoplasms Carcinoma, Ovarian Epithelial Albumin-Bound Paclitaxel VB-111 + Paclitaxel

Eligibility

You can join if…

Open to females ages 18 years and up

  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:
  7. ANC ≥ 1000/mm3
  8. PLT ≥ 100,000/mm3
  9. PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
  10. 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).

You CAN'T join if...

  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 whole abdomen.
  6. Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula):
  7. Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
  8. Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).
  9. Inadequate renal function, defined as:
  10. Serum creatinine > ULN OR
  11. Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
  12. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  13. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
  14. . History of stroke or transient ischemic attack within 6 months prior to day of randomization.
  15. . Patient with proliferative and/or vascular retinopathy
  16. . Known brain metastases
  17. . History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
  18. . Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  19. . History of abdominal fistula or gastrointestinal perforation.
  20. . Current signs and symptoms of bowel obstruction
  21. . Uncontrolled active infection
  22. . 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

Locations

  • University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Krishnansu Tewari, MD
    Professor, Obstetrics And Gynecology. Authored (or co-authored) 182 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
Links
VBL Therapeutics Company Website OVAL study Website
ID
NCT03398655
Phase
Phase 3
Study Type
Interventional
Last Updated