CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Cobimetinib +1 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/NCT02457793
NCT02457793Phase 1Completed

A Phase Ib, Open-Label, Dose-Escalation Study Of The Safety, Tolerability, and Pharmacokinetics of Cobimetinib and GDC-0994 In Patients With Locally Advanced or Metastatic Solid Tumors

Genentech, Inc.·interventional·Posted May 29, 2015·Updated Nov 20, 2018

In Brief

A Phase 1 clinical trial evaluating Cobimetinib and GDC-0994 for Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma. Completed, enrolled 24 participants across 5 sites.

Detailed Summary

This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or metastatic solid tumors for which standard therapies either do not exist or have proven ineffective or intolerable.

Study Details

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

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 29, 2015
Enrollment StartJun 16, 2015
Primary CompletionDec 5, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.1 years ago

Interventions

Cobimetinibdrug

Cobimetinib given concurrently or intermittently with GDC-0994 for 21 consecutive days followed by 7 days off.

GDC-0994drug

GDC-0994 given for 21 consecutive days followed by 7 days off, along with concurrent or intermittent dosing of cobimetinib.