Health Condition 1: null- Endometrial Cancer
Conditions
Interventions
Intervention1: Ridaforolimus (Formerly Deforolimus): Ridaforolimus will be administered orally at a dose of 40 mg QD for five consecutive days followed by a two-day holiday, each week.
Total treatmen
Sponsors
ARIAD Pharmaceuticals Inc
Merck Sharp and Dohme Corp
Eligibility
Inclusion criteria
Inclusion criteria: 18 years of age or older - Endometrial cancer - Patients must have been treated with one cytotoxic regimen - 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 18 years of age or older - Endometrial cancer - Patients must have been treated with one cytotoxic regimen - 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 criteria
Exclusion criteria: More than one prior regimen of cytotoxic chemotherapy - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS)Timepoint: Time from the date of randomization to the date of documented progressive disease, recurrence or death (whichever occurs first) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression-free survival of patients receiving deforolimum versus progestin. 2.Overall survival of patients receiving deforolimus versus progestin 3.Best response rates in patients receiving deforolimus versus progestin 4.Safety and tolerability of oral deforolimusTimepoint: Comparison of progression-free survival of patients receiving deforolimum versus progestin at 16 weeks and 26 weeks post-randomization. | — |
Countries
Canada, Chile, Czech Republic, Germany, India, Italy, Spain, Switzerland, United Kingdom, United States of America
Contacts
Public ContactJayesh Mahajan
Medpace Clinical Research India Pvt. Ltd.
Outcome results
None listed