Trials / Active Not Recruiting
Active Not RecruitingNCT01267955
Vismodegib in Treating Patients With Advanced Chondrosarcomas
A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Clear Cell Chondrosarcoma
- Dedifferentiated Chondrosarcoma
- Locally Advanced Chondrosarcoma
- Mesenchymal Chondrosarcoma
- Metastatic Chondrosarcoma
- Primary Central Chondrosarcoma
- Unresectable Primary Central Chondrosarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Pharmacogenomic Study | Correlative studies |
| DRUG | Vismodegib | Given PO |
Timeline
- Start date
- 2010-12-21
- Primary completion
- 2018-06-30
- Completion
- 2026-07-21
- First posted
- 2010-12-29
- Last updated
- 2026-04-13
- Results posted
- 2019-11-15
Locations
6 sites across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01267955. Inclusion in this directory is not an endorsement.