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

Completed · Phase 1

Conditions studied: Solid Cancers

In brief

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.

Key facts

Study ID

NCT01209143

Run by

Genentech, Inc.

People needed

52

Starts

2010-11-01

Expected to finish

2012-03-01

Last updated by the study team

2015-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy
• Documented negative serum pregnancy test for women of childbearing potential and use of two forms of contraception. Contraception must be used while the patient is enrolled in the study and for 12 months after the patient discontinues from the study.
• For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 3 months after their last dose of GDC-0449.
• Agreement not to donate blood or blood products during the study and for at least 12 months after their last dose of GDC-0449
• For male patients, agreement not to donate sperm during the study and for at least 3 months after their last dose of GDC-0449
• Adequate hematopoietic capacity
• Adequate renal function
• Adequate hepatic function
• At least 3 weeks since the patient's last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities

You may not qualify if…

• Active infection requiring intravenous (IV) antibiotics
• Clinically important history of liver disease significantly impairing hepatic function, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
• Any medical condition or diagnosis that would likely impair absorption of an orally administered drug
• Pregnant or lactating
• Treatment with excluded medications, including strong CYP450 inhibitors and inducers, within 2 weeks of study entry
• Male patients already receiving rosiglitazone
• Male patients with a known contraindication to rosiglitazone
• Female patients already receiving oral contraception < 14 days prior to Day 1
• Female patients with known contraindication to oral contraceptions

Where it is running

• Study site — Stanford, California, United States
• Study site — Detroit, Michigan, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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