NCT01209143

A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive 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, Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive 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: 52 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced solid tumors who are refractory to treatment or for whom no standard therapy exists.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
DRUG	Vismodegib	Vismodegib was supplied in hard gelatin capsules.
DRUG	Rosiglitazone	Rosiglitazone was supplied in tablets.
DRUG	Norethindrone/ethinyl estradiol	Norethindrone/ethinyl estradiol was supplied in tablets.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-09-27
• Last updated: 2015-06-29
• Results posted: 2015-06-29

Locations

3 sites across 1 country: United States