Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients
This is a phase II study which will test the study drug MLN0128 in patients with castration resistant prostate cancer who have received chemotherapy in the past. Phase II clinical trials test how well an investigational drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. MLN0128 is not approved by the FDA.
The purpose of this study is to see what effects (good and bad) the study drug MLN0128 has on the patient and the cancer. MLN0128 is a drug that belongs to a class of drugs called "mTOR kinase inhibitors". A protein, called "mTOR" inside the cells in the body, plays a role in controlling how cells grow. In some cancer cells, mTOR may be over-active. This over-activity may cause some cancer cells to grow out of control. Research has shown that mTOR inhibitors can block this overactivity and may help stop or slow down the growth of some types of cancer cells.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of the Dual mTOR Inhibitor MLN0128 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)|
- Progression-free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]from the start of treatment, as defined by the Prostate Cancer Working Group 2 (PCWG2) guidelines.
- PSA response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Summary tables and waterfall plots describing change in PSA relative to baseline will be reported at 8 weeks (or earlier for those who discontinue therapy), and separately, the maximal change at any time on study will also be reported for each patient using summary tables and waterfall plots.
- radiographic response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]We propose to study both FDG and optional FDHT PET imaging at baseline, 4 weeks after treatment initiation and at the time of progression (end-of-treatment), and to correlate the changes with treatment response. Response and progression will be evaluated in this study using a combination of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee and modified for prostate cancer and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2).21
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Patients will be treated with the established phase II dose of MLN0128 (4mg po daily continuously; 1 cycle=4 weeks) to assess mechanisms of sensitivity and resistance in men with CRPC who have received either enzalutamide and/or abiraterone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02091531
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Dana Rathkopf, MD||Memorial Sloan Kettering Cancer Center|