Trial ID or NCT#

NCT01357161

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc
Gynecologic oncologist
Laurie Kraus Lacob Professor
Nelson Teng

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CONTACT

CCTO
(650) 498-7061