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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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
