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