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: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Adavosertib; Cisplatin; Topotecan

Criteria

Inclusion Criteria:

• Has advanced, metastatic, and recurrent squamous cell, adenosquamous, or adeno-carcinoma of the uterine cervix (Stage II - IVb)

• Has received cisplatin in combination with radiation as initial or adjuvant treatment for their cervical cancer

• Has not received any other treatment for their cancer following the cisplatin-based chemo-radiation or targeted therapy except non-cytotoxic targeted therapy

• Recurrence must be at least 6 months post cisplatin-based chemotherapy

• Has measurable disease

• Performance status on the Eastern Cooperative Oncology Group (ECOG) Performance Scale is less than or equal to 1

• Has a negative pregnancy test within 72 hours of the first dose of study medication

Exclusion Criteria:

• Has had chemotherapy, radiotherapy, or biological therapy within 6 months of entering the study

• Has a history of vascular thrombotic events or vascular reconstruction

• Has active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Has a primary CNS tumor

• Requires the use of medications or products that are metabolized by, or inhibit or induce CYP3A4 (Cytochrome P450 3A4)

• Is expecting to reproduce within the duration of the study or is pregnant or breastfeeding

• Is known to be Human Immunodeficiency Virus (HIV)-positive

• Has known active Hepatitis B or C

• Has a known history of interstitial lung disease or pulmonary fibrosis

• Has symptomatic ascites or pleural effusion

• Has a clinical history suggestive of Li-Fraumeni Syndrome