Clinical Trial TitleThe 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 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.