NCT02639546

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Cobimetinib In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 6 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Cobimetinib	Cobimetinib tablet or suspension will be administered as per the schedule described in arm description.

Timeline

• Start date: 2016-05-20
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2015-12-24
• Last updated: 2022-09-16
• Results posted: 2022-03-31

Locations

17 sites across 7 countries: United States, France, Germany, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study