Single-agent Cobimetinib for Adults With Histiocytic Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02649972|
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Histiocytic Disorders||Drug: Cobimetinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Single-agent Cobimetinib for Adults With Histiocytic Disorders|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
This is an open-label, single-center, phase II study exploring the efficacy and safety of single-agent Cobimetinib in patients with histiocytic disorders whose tumors are 1) BRAFV600 wildtype or 2) BRAFV600E mutant and are intolerant to, or unable to access, BRAF inhibitors.
Patients in this study will receive single-agent Cobimetinib 60mg oral daily for days 1-21 of each 28 day cycle. The rationale for single agent therapy, is the evidence for robust and sustained response to BRAF inhibitor monotherapy in histiocytic disorders harboring the BRAFV600E mutation. Patients will have the option to discontinue treatment after 12 cycles and will be monitored for disease relapse for an additional 12 months. In the event that disease relapse occurs within the 12 month monitoring period, patients will restart treatment and continue on study. Upon restarting, the assessment schedule will restart at replase cycle 1(RC-1) and all assessments will occur at the frequency and intervals. Cycle 1 Day 15 visits will not be required for patients that restart treatment after relapse during the monitoring period.
- best overall response [ Time Frame: 1 year ]by PET Response Criterial (PRC), with a dichotomous BOR of CR or PR versus neither of those. Assuming we use this binary endpoint of response, defined as best overall response of CR or PR versus not using the PET Response Criteria (PRC), a sample size of 18 patients provides 90% power to test the hypothesis that the response rate is promising (defined as 35% or higher) against a non-promising rate of 10% or lower.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649972
|Contact: Eli Diamond, MD||212-639-7576|
|Contact: David Hyman, MD||646-888-4544|
|United States, New York|
|Memoral Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Eli Diamond, MD 212-639-7576|
|Contact: David Hyman, MD 646-888-4544|
|Principal Investigator: Eli Diamond, MD|
|Principal Investigator:||Eli Diamond, MD||Memorial Sloan Kettering Cancer Center|