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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01076400
• Date of registration: 24/02/2010
• Primary sponsor: Merck
• Public title: A Study of MK1775 in Combination With Topotecan/Cisplatin in Patients With Cervical Cancer (1775-008)
• Scientific title: A Two Part, Phase I-IIa Study Evaluating MK1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical Cancer
• Date of first enrolment: May 2010
• Target sample size: 7
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01076400
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Brazil, Canada, France, Korea, Republic of, Netherlands, Norway, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- Patient has received cisplatin in combination with radiation as initial or adjuvant
treatment for their cervical cancer

- Patient 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

- Patient has measurable disease

- Patient's performance status on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale is less than or equal to 1

- Patient has a negative pregnancy test within 72 hours of the first dose of study
medication

Exclusion Criteria:

- Patient has had chemotherapy, radiotherapy, or biological therapy within 6 months of
entering the study

- Patient has a history of vascular thrombotic events or vascular reconstruction

- Patient has active central nervous system (CNS) metastases and/or carcinomatous
meningitis

- Patient has a primary CNS tumor

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

- Patient is expecting to reproduce within the duration of the study or is pregnant or
breastfeeding

- Patient is known to be Human Immunodeficiency Virus (HIV)-positive

- Patient has known active Hepatitis B or C

- Patient has a known history of interstitial lung disease or pulmonary fibrosis

- Patient has symptomatic ascites or pleural effusion

- Patient has a clinical history suggestive of Li-Fraumeni Syndrome



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Drug: Comparator: MK1775 + topotecan + cisplatin

Drug: Comparator: Placebo to MK1775 + topotecan + cisplatin

Drug: MK1775 + topotecan + cisplatin

Primary Outcome(s)

Part 1: Maximum tolerated dose as determined by the number of dose limiting toxicities (DLTs) per dose level [Time Frame: End of Cycle 1 (1 Cycle = 21 Days)]

Part 1: Objective response rate [Time Frame: Treatment response will be measured every two cycles (1 cycle = 21 days)]

Part 2: Progression-free survival [Time Frame: Tumor progression will be assessed every two cycles (1 Cycle = 21 Days)]

Secondary ID(s)

2010_515

MK1775-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors