NCT02649972

Single-agent Cobimetinib for Adults With Histiocytic Disorders

Phase II Trial of Single-agent Cobimetinib for Adults With Histiocytic Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects, good or bad, Cobimetinib has in patients with histiocytosis. Cobimetinib is an investigational oral medication that blocks MEK1.

Conditions

• Histiocytic Disorders

Interventions

Type	Name	Description
DRUG	Cobimetinib	Cobimetinib will be administered at a dose of 60mg daily for 21 days on, then 7 days off, in a 28 day treatment cycle. 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 rechallenge 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. Participants will re-sign consent upon rechallenging.

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2016-01-08
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

2 sites across 1 country: United States