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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
To evaluate the efficacy of the combination of intravenous administration of VB-111 and paclitaxel compared to placebo and paclitaxel in patients with platinum resistant ovarian cancer as measured by Overall Survival (OS).
Lea Russell at firstname.lastname@example.org
18 year(s) or older
Inclusion Criteria:Histologically confirmed epithelial ovarian cancer and documented disease.
Patients must have platinum-resistant disease
Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
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.
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).
Exclusion Criteria:Non-epithelial tumors (Carcino-sarcomas are excluded)
Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
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
Previous ovarian cancer treatment with >5 anticancer regimens.
Any prior radiotherapy to the pelvis or whole abdomen.