advanced endometrial carcinoma MedDRA version: 9.1 Level: LLT Classification code 10014747 Term: Endometrial carcinoma recurrent MedDRA version: 9.1 Level: LLT Classification code 10014745 Term: Endometrial carcinoma metastatic
Conditions
Interventions
Product Name: Deforolimus
Product Code: AP23573 or MK-8669
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: deforolimus
Sponsors
ARIAD Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.=18 years of age. 2.Patients must have unresectable stage III or IVa, or metastatic (stage IVb), or recurrent histologically-confirmed endometrial cancer. 3.Endometrial cancer will include all carcinomas, including endometrioid carcinoma, papillary serous carcinoma, clear cell carcinoma, and carcinosarcomas. Leiomyosarcomas are not included. 4.Patients must have been treated with one cytotoxic regimen either: 1. As first line therapy for recurrent or metastatic disease, with documented disease progression after treatment, or 2. As adjuvant therapy, in which case the patient must have documented disease recurrence 1.5 x ULN, then alkaline phosphatase liver fraction must be =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.More than one prior regimen of cytotoxic chemotherapy. 2.Prior therapy with hormonal agents. 3.Women who are pregnant or lactating. 4.Presence of brain or other central nervous system metastases. 5.Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents. 6.Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization. The interval must be = 6 weeks for prior nitrosourea or mitomycin therapy. 7.Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of = grade 1 by NCI toxicity criteria). 8.Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization. Patients who have recovered from placement of a central venous access port within 2 weeks of Cycle 1 Day 1 will be considered eligible. 9.Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ). 10.Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin). 11.Significant uncontrolled cardiovascular disease including NYHA class III-IV heart failure, unstable angina, or a myocardial infarction within the last six months. 12.Active infection requiring systemic therapy. 13.Known HIV infection. 14.Known hepatitis B or C infection. 15.Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes. 16.Concurrent treatment with immunosuppressive agents. 17.Patient has a requirement for concurrent treatment with medications that strongly induce or inhibit cytochrome P450 (CYP3A). Patients should be off these medications = 2 weeks prior to the first dose of deforolimus. 18.Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient’s safety or interfere with evaluating the safety of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one prior chemotherapy regimen for advanced disease when treated with deforolimus or progestin.;Primary end point(s): The primary endpoint is progression-free survival, defined as the time from the date of randomization to the date of documented progressive disease, recurrence or death (whichever occurs first).; Secondary Objective: •To compare the proportion of patients receiving deforolimus versus progestin who are progression-free at 16 weeks and 26 weeks post randomization as assessed using modified RECIST guidelines. •To compare the overall survival (OS) of patients receiving deforolimus versus progestin. •To compare the best response rate of patients receiving deforolimus versus progestin. •To assess the safety and tolerability of oral deforolimus in this patient population. Exploratory Objective: •To assess changes in Quality of Life parameters in those patients treated with deforolimus compared to those treated with progestin as an exploratory objective | — |
Countries
Czech Republic, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed