NCT04409639

Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations

Phase 2 Trial of Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, nonrandomized phase 2 trial to assess the efficacy of cobimetinib in RAS pathway activated CMML. All eligible patients will be treated daily with cobimetinib in 28-day cycles. Cobimetinib will be administered for three weeks followed by a one week break prior to the start of the following cycle. Patients will remain on study therapy until treatment discontinuation criteria is met.

Detailed description

This is an open-label, nonrandomized phase 2 trial to assess the efficacy of cobimetinib in RAS pathway activated CMML. Two cohorts of patients will be accrued using Simon's two-stage design (Simon, 1989) for both cohorts. Cohort 1 will enroll nine newly diagnosed patients in the first stage and if four or more responses are observed five additional patients will be enrolled in the second stage. Cohort 2 will enroll six HMA refractory patients in the first stage and if one or more responses are observed then nine additional patients will be enrolled in the second stage. All eligible patients will be treated daily with cobimetinib in 28-day cycles. Cobimetinib will be administered consecutively for three weeks followed by a one week break prior to the start of the following cycle. Patients will remain on study therapy until treatment discontinuation criteria is met.

Conditions

• Chronic Myelomonocytic Leukemia (CMML)

Interventions

Type	Name	Description
DRUG	Cobimetinib	Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.

Timeline

• Start date: 2021-01-12
• Primary completion: 2025-04-02
• Completion: 2026-08-01
• First posted: 2020-06-01
• Last updated: 2026-02-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study