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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Correlative studies
Given PO
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Cmax Following Single Dose of Drug
Highest observed concentration over the 168 hour period. Blood samples were collected at j0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 24, 48, 120, and 168 hours.
Time frame: 168 hours
AUC Following Single Dose of Drug
Area under the curve from 0-168 hours.
Time frame: 168 hours
Tmax'Following Single Dose of Drug
Time of maximum drug concentration
Time frame: 168 hours
Tlag Following Single Dose of Drug
Time between drug administration and when it is first observed in the systemic circulation.
Time frame: 168 hours
Ctrough Following Steady State Exposure for 14 Days
Minimum blood concentration over 24-hour observation period. Blood sample collected at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 24 hours.
Time frame: 24 hours
Cmax Following Steady State Exposure for 14 Days
Maximum drug concentration over 24 hours.
Time frame: 24 hours
AUC Following Steady State Exposure for 14 Days
Area under the curve from 0 to 24 hours.
Time frame: 24 hours
Tmax Following Steady State Exposure for 14 Days
Time of maximum drug concentration.
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Objective Responses in Patients With Solid Tumors
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 30 days