Status:
COMPLETED
Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines ...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Endometrial cancer
- Patients must have been treated with at least one line of chemotherapy, but not more than two lines of chemotherapy, and experienced progressive disease
- At least one measurable lesion
- ECOG performance status less than or equal to 1
- Minimum life expectancy of 3 months
- Adequate renal and hepatic function
- Adequate bone marrow function
- Serum cholesterol \<350 mg/dL and triglycerides \< 400 mg/dL
- Able to understand and give written informed consent
- Females of childbearing potential must have a negative pregnancy test and use approved contraception from screening to 30 days after the last study drug is given
Exclusion
- Two lines of chemotherapy for recurrent or metastatic disease
- Chemotherapy for recurrent or metastatic disease administered within six months of adjuvant therapy
- More than two lines of chemotherapy of any type
- Prior therapy with hormonal agents
- Women who are pregnant or lactating
- Presence of brain or other central nervous system metastases
- Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents
- Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization
- Ongoing toxicity associated with prior anticancer therapy
- Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization.
- Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ)
- Known Grade 3 or 4 hypersensitivity to macrolide antibiotics
- Significant uncontrolled cardiovascular disease
- Active infection
- Known HIV infection
- Known Hepatitis B or C infection
- Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes
- Concurrent treatment with immunosuppressive agents
- A requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A)
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00739830
Start Date
August 1 2008
End Date
July 1 2012
Last Update
July 1 2015
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