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VB-111-70 (OVAL): A randomized, controlled, double-arm, double-blind, multi-center study of ofranergene obadenovec (VB-111) combined with paclitaxel versus paclitaxel combined with placebo for the treatment of recurrent platinum-resistant ovarian cancer

Description

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.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to determine overall survival.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are female and at least 18 years old
  • Have histologically confirmed epithelial ovarian cancer and documented disease
  • Have platinum-resistant disease
  • Have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
  • Have ECOG PS 0-1
  • Have 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.
  • Are known to carry a BRCA mutation, following PARP inhibitor treatment failure, intolerant of, or ineligible for PARP inhibitor treatment

Excluding patients who:

  • Have non-epithelial tumors (Carcino-sarcomas are excluded)
  • Have ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors
  • Have a History of other clinically active malignancy within five 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
  • Have previous ovarian cancer treatment with more than five anticancer regimens
  • Have any prior radiotherapy to the pelvis or abdomen
  • Have 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).
  • Have inadequate renal function, defined as:
    • Serum creatinine > ULN OR
    • Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
  • Have New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Have a history of myocardial infarction or unstable angina within six months prior to day of randomization.
  • Have a history of stroke or transient ischemic attack within 6 months prior to day of randomization
  • Have proliferative and/or vascular retinopathy
  • Have known brain metastases
  • Have a history of hemoptysis or active GI bleeding within six months prior to day of randomization
  • Have evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Have a history of abdominal fistula or gastrointestinal perforation
  • Have current signs and symptoms of bowel obstruction
  • Have uncontrolled active infection
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Julian Schink

Natalie Godbee