Vismodegib in Treating Patients With Advanced Chondrosarcomas
This phase II trial is studying how well vismodegib works in treating patients with advanced chondrosarcomas. Drugs used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Other: diagnostic laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas|
- Clinical benefit (CR + PR + SD) rate [ Time Frame: At 6 months ] [ Designated as safety issue: No ]At six months, patients will be classified as success (alive at 6 months AND CR/PR/ SD) or failure (dead OR alive with progression).
- Progression-free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
- Duration of response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Will be described in responding subjects using descriptive statistics (median, extreme values, etc.).
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (vismodegib)
Patients receive vismodegib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicities.
Other Names:Other: diagnostic laboratory biomarker analysis
I. Evaluate the antitumor activity of GDC-0449 (vismodegib) in terms of 6-month clinical benefit rate (complete response, partial response, and stable disease, as per the revised RECIST criteria 2009).
I. Determine the best overall response (as per the revised RECIST criteria 2009).
II. Determine the 1- and 2-year progression-free survival. III. Determine the 1- and 2-year overall survival. IV. Assess GDC-0449 safety. V. Conduct a pharmacogenomic analysis of predictive markers of treatment outcome.
OUTLINE: This is a multicenter study.
Patients receive vismodegib orally (PO) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicities.
Tumor samples are analyzed for correlative, including biomarker, studies.
After completion of study therapy, patients are followed up every 3 months.
|Institut Bergonie Cancer Center|
|Bordeaux, France, 33000|
|Centre Oscar Lambert|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Hopital De La Timone|
|Marseille, France, 13005|
|Institut Curie Paris|
|Paris, France, 75005|
|Institut Gustave Roussy|
|Villejuif, France, 94805|
|Principal Investigator:||Antoine Italiano||Institut Bergonie Cancer Center|