A Study of MK-1775 in Combination With Topotecan/Cisplatin in Participants With Cervical Cancer (MK-1775-008)
Status:
Terminated
Trial end date:
2011-06-13
Target enrollment:
Participant gender:
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. The primary hypothesis is the combination of
MK-1775, topotecan and cisplatin causes objective radiological responses (assessed per
Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) in ≥30% of participants.
Due to the early termination of the study by the sponsor, no participants were enrolled in
Part 2 of the study.