Status: Closed
Activation Date: 2008AUG26
Closing Date: 2010AUG11
Phase: II
Description: A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of deforolimus activation. Prior hormonal treatment (adjuvant or metastatic), but no prior chemotherapy permitted.
Objective: To assess the efficacy (response rate and duration of stable disease) of ridaforolimus given orally, once daily, 5 days/week continuously in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of ridaforolimus in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour).
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to find out how effective the experimental drug ridaforolimus is in treating endometrial cancer. In addition, this study will look at the side effects of ridaforolimus. Treatment will be ridaforolimus once daily by mouth for 5 days a week. Treatment will continue as long as the cancer does not get worse and the side affects are not too severe and the patient wishes to continue.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I192 | 35 | 16 | 34 | 34 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I192 | 35 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I192 | 35 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |