A Study of MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004)

• Status: Completed
• Trial end date: 2016-08-08

Summary

This is a study of the safety and efficacy of MK-1775 in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation. In Part 1, a small group of participants will receive MK-1775 along with paclitaxel plus carboplatin to establish the tolerability of MK-1775 with this combination. In Part 2, participants will be randomly assigned to receive either MK-1775 plus paclitaxel and carboplatin OR placebo plus paclitaxel and carboplatin to assess efficacy of MK-1775 compared to placebo. The primary hypothesis of the study (Part 2) is that administration of MK-1775 in combination with paclitaxel plus carboplatin in participants with platinum sensitive p53 mutant ovarian cancer will result in improvement in progression free survival (PFS) per enhanced Response Evaluation Criteria In Solid Tumors version 1.1 (enhanced RECIST 1.1) compared to participants treated with paclitaxel plus carboplatin alone.

• Phase: Phase 2

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Adavosertib; Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel