CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Cobimetinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02639546
NCT02639546Phase 2Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Dec 24, 2015·Updated Sep 16, 2022

In Brief

A Phase 2 clinical trial evaluating Cobimetinib for Solid Tumors. Completed, enrolled 56 participants across 17 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesFrance, Germany, Israel, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 24, 2015
Enrollment StartMay 20, 2016
Primary CompletionJul 21, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.5 years ago

Interventions

Cobimetinibdrug

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