NCT00968981

A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

A Phase Ib, Open-Label, Dose-Scheduling Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
DRUG	GDC-0449	Daily oral repeating dose
DRUG	GDC-0449	Three times weekly oral repeating dose
DRUG	GDC-0449	Once weekly oral repeating dose

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-08-31
• Last updated: 2017-07-11
• Results posted: 2015-12-09