MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin
Research type
Research Study
Full title
A Randomised, 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
IRAS ID
107611
Contact name
Susana Banerjee
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2011-002803-13
Clinicaltrials.gov Identifier
Research summary
Ovarian cancer is one of the leading causes of cancer deaths among women world-wide. Approximately 70% of patients are diagnosed at an advanced stage, as the disease typically has no symptoms. Newer and more effective treatments are needed. This is a multicenter, worldwide, double-blind, randomised, Phase II study of paclitaxel carboplatin (standard of care anti-cancer treatments) with or without an experimental drug known as MK-1775 administered in patients with platinum sensitive p53 mutant ovarian cancer. Platinum sensitive is defined as -progression of cancer occurs 6 months or more after the last platinum based treatment regimen. Carboplatin is a platinum anti-cancer treatment . p53 ?? is a protein involved in the regulation of cell growth and division. The study will be conducted in two parts. Part 1 will establish the tolerability of MK1775 with carboplatin and paclitaxel. Part 2 is a randomised comparison between MK-1775 paclitaxel carboplatin vs placebo paclitaxel carboplatin. The UK will take part in Part 2 of the study only. Treatment will be given in 21 day cycles. Participants will take a total of 5 doses of MK1775/placebo by mouth for the first two and half days of each cycle. Paclitaxel and caboplatin will be given as intravenous infusions on day one of each cycle. Participants will be on study treatment for 6 cycles or until disease progression or discontinuation. Blood for CA-125 (a marker of ovarian cancer) will be collected every 3 weeks and CT or MRI scans will be performed every 6 weeks (from start of study treatment regardless of cycle day) to measure response to treatment . World-wide up to 119 patients will be enrolled in the study (13 to 39 in part 1 and 80 in part 2) It is anticipated that 3 UK NHS hospital sites will participate in the study.
REC name
London - Fulham Research Ethics Committee
REC reference
12/LO/1236
Date of REC Opinion
25 Sep 2012
REC opinion
Further Information Favourable Opinion