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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Part 1: Objective response rate

Outcome Time Frame:

Treatment response will be measured every two cycles (1 cycle = 21 days)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

2010_515

NCT ID:

NCT01076400

Start Date:

May 2010

Completion Date:

June 2011

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms

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