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Treatment Study for Recurrent Platinum-Resistant Ovarian Cancer

Clinical Trial Title: 
The OVAL study: 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.
Clinical Trial Protocol ID: 
17062008
Clinical Trial Investigator Name: 
Summer B. Dewdney, MD
Clinical Trial Protocol Description: 

The purpose of this phase 3, randomized, multi-center study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with recurrent platinum-resistant ovarian cancer.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are a female patient at least 18 years of age.
  • 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.

You will be excluded from the study if any of the following criteria apply to you:

  • 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 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.
  • Have had previous ovarian cancer treatment with >5 anticancer regimens.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gynecologic Cancers
Contact Phone: 
(312) 942-2417
Contact Name: 
Lois Winkelman