A Study of MK1775 in Combination With Topotecan/Cisplatin in Patients With Cervical Cancer (1775-008)

Official Title

A Two Part, Phase I-IIa Study Evaluating MK1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical Cancer

Summary:

This study will be conducted in two parts. Part 1 will determine whether administration of MK1775 in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. Part 1 will also define the recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of MK1775 with topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with MK1775 in combination with topotecan and cisplatin causes an improvement in progression-free survival (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the tolerability of the combination treatment.

Trial Description

Primary Outcome:

• Part 1: Objective response rate
• Part 1: Maximum tolerated dose as determined by the number of dose limiting toxicities (DLTs) per dose level
• Part 2: Progression-free survival

View this trial on ClinicalTrials.gov