Spots Global Cancer Trial Database for Unesbulin in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy

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Trial Identification

Brief Title: Unesbulin in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy

Official Title: Phase 1B Trial With Unesbulin in High-Grade Serous Ovarian Cancer: a Targeted Approach Toward Chemoresistant Stem-Like Cancer Cells

Study ID: NCT03206645

Conditions

Ovarian Cancer

Interventions

Unesbulin

Study Description

Brief Summary: This is an open-label Phase Ib dose-escalation study to determine the safety, tolerability, and pharmacokinetics of Unesbulin when combined with and following conventional chemotherapy and as maintenance therapy as a capsule (weight based dosing) and a tablet (fixed dosing) in women with epithelial ovarian, fallopian tube or primary peritoneal cancer which is previously untreated.

Detailed Description: For all cohorts, the study drug Unesbulin will be orally administered prior to chemotherapy (paclitaxel and carboplatin), twice a week of each 21-day cycle. Chemotherapy will be administered on day 1 of each cycle by vein. Dose escalation levels for Unesbulin will occur per protocol and doses may be de-escalated for management of toxicity. Patients will receive a total of 3 cycles of Unesbulin and chemotherapy. Surgery will be performed within 6 weeks after the last dose of Cycle 3. An additional 3-7 cycles of Unesbulin and chemotherapy (carboplatin and paclitaxel) may be given as maintenance therapy for up to two years at the discretion of the treating physician.