NCT01174264

Evaluation of Food Effect on Pharmacokinetics of Vismodegib

Evaluation of Food Effect on Pharmacokinetics of GDC-0449, an Inhibitor of Hedgehog Signaling

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial studies the effect of food on the pharmacokinetics of vismodegib. Studying the effects of meals on the absorption of vismodegib may help doctors prescribe correct doses and label the drug accurately.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the effect of prandial states on the pharmacokinetic parameters of GDC-0449 (vismodegib). II. To evaluate the effect of fat content of meals on the pharmacokinetic parameters of GDC-0449. SECONDARY OBJECTIVES: I. To evaluate the effect of prandial states and fat content of meals on the safety profile of GDC-0449. II. To describe any anticancer activities of GDC-0449. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive a single dose of vismodegib orally (PO) on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28. ARM II: Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28. ARM III: Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28. In all arms, treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Pharmacological Study	Correlative studies
DRUG	Vismodegib	Given PO

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-08-03
• Last updated: 2017-05-19
• Results posted: 2016-03-15

Locations

1 site across 1 country: United States