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

Official Title

A Randomized, Phase II Study Evaluating MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Adult Patients With Platinum Sensitive p53 Mutant Ovarian Cancer

Summary:

This is a study of the safety and efficacy of MK-1775 in combination with paclitaxel + carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumours with the P53 mutation. In Part 1, a small group of participants will receive MK-1775 along with paclitaxel and carboplatin to find the maximum tolerable MK-1775 dose for this combination. Pharmacokinetics will also be assessed during this period. In Part 2, participants will be randomly assigned to receive either MK-1775 + paclitaxel + carboplatin or placebo + paclitaxel + carboplatin.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS)
Secondary Outcome:
  • Objective response rate (ORR)
  • Overall survival (OS)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society