CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 119 enrolled
Drug / intervention
cobimetinib +2 moredrug
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/NCT00467779
NCT00467779Phase 1Completed

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0973/XL518 Administered Orally Daily to Subjects With Solid Tumors

Genentech, Inc.·interventional·Posted May 1, 2007·Updated Aug 26, 2016

In Brief

A Phase 1 clinical trial evaluating cobimetinib, dextromethorphan, and 1 other intervention for Solid Tumor. Completed, enrolled 119 participants across 4 sites.

Detailed Summary

This non-randomized, open-label, study will determine the highest safe dose of cobimetinib, how often it should be taken, how well participants with cancer tolerate cobimetinib and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 1, 2007
Enrollment StartMay 1, 2007
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 19.2 years ago

Interventions

cobimetinibdrug

Repeating oral dose

dextromethorphandrug

In Stage III only: single dose of dextromethorphan

midazolamdrug

In Stage III only: single dose of midazolam