Status:
COMPLETED
A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit); patients with basal cell carcinoma will be excluded from this study unless they do not qualify for another open GDC-0449 clinical trial
- For patients with disease that is evaluable by physical examination only, diagnosis must also include biomarker confirmation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Documented negative pregnancy test for women of childbearing potential and agreement to use an effective form of contraception for the duration of the study
- Adequate hematopoietic capacity
- Adequate hepatic function
- Adequate renal function
- At least 3 weeks since last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities
- Exclusion Criteria
- Known, untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
- Active infection requiring intravenous (IV) antibiotics
- Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis
- Any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis)
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
- Pregnant or lactating
- Treatment with excluded medications, including strong CYP450 inhibitors and inducers
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00968981
Start Date
September 1 2009
End Date
October 1 2010
Last Update
July 11 2017
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