At a glance
ClinicalIndex Comparison Record- ✓Biopsy-proven Langerhans Cell Histiocytosis (LCH)
- ✓LCH with failure of at least front-line therapy and evaluable disease
- ✓LCH-associated neurodegenerative disease with radiologic or clinical progression within 3 months
- ✓Biopsy-proven JXG, ECD, RDD, histiocytic sarcoma, or other histiocytic lesion with evaluable active disease
- ✕Prior treatment with cobimetinib
- ✕Strong inducers or inhibitors of CYP3A4 within 14 days prior to enrollment
- ✕Radiation therapy within 14 days prior to enrollment
- ✕Hematopoietic growth factors: long-acting within 14 days or short-acting within 7 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04079179Phase 2RecruitingUpdate OverdueUpdated 9mo ago · Completion was 6mo agoA Phase 2 Study to Assess the Safety and Efficacy of Cobimetinib in Refractory Langerhans Cell Histiocytosis, LCH-Associated Neurodegenerative Disease, and Other Histiocytic Disorders.
In Brief
A Phase 2 clinical trial evaluating Cobimetinib for Langerhan's Cell Histiocytosis and 6 related conditions. Currently recruiting, targeting 90 participants across 12 sites.
Signals
Detailed Summary
This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK) that is part of incorrect growth signals in histiocytosis cells. Four different groups of patients will be enrolled.
Study Details
Timeline
Interventions
Cobimetinib will be administered at a maximal dose of 60 mg daily for patients \<18 years old and a flat dose of 40 mg daily for patients ≥18 years for 21 days on, then 7 days off, in a 28-day treatment cycle for a total of 12 cycles (approximately 12 months).