drugset
drugset / Trial / 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

NCT01209143 ↗

Phase 1 Completed 52 enrolled Genentech, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-11
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Norethindrone/ethinyl estradiol Unknown 35 ug Oral
Subject Norethindrone/ethinyl estradiol Unknown 1 mg Oral
Subject Rosiglitazone Small molecule 4 mg Oral
Subject Vismodegib Small molecule 150 mg Oral

Indications

No indication recorded.