Vismodegib in Treating Patients With Advanced Chondrosarcomas

Mesenchymal Chondrosarcoma Clinical Trial

Official title: A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies how well vismodegib works in treating patients with chondrosarcomas that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To 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 Response Evaluation Criteria in Solid Tumors [RECIST] criteria 2009).

SECONDARY OBJECTIVES:

I. Best overall response (as per the revised RECIST criteria 2009). II. 1- and 2-year progression-free survival. III. 1- and 2-year overall survival. IV. GDC-0449 safety. V. Pharmacogenomics analysis of predictive markers of treatment outcome.

OUTLINE:

Patients receive vismodegib orally (PO) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months. ;

Related Conditions & MeSH terms

• Chondrosarcoma
• Clear Cell Chondrosarcoma
• Dedifferentiated Chondrosarcoma
• Locally Advanced Chondrosarcoma
• Mesenchymal Chondrosarcoma
• Metastatic Chondrosarcoma
• Primary Central Chondrosarcoma
• Unresectable Primary Central Chondrosarcoma

• NCT number: NCT01267955
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 21, 2010
• Completion date: July 25, 2024