Vismodegib in Treating Patients With Advanced Chondrosarcomas
|ClinicalTrials.gov Identifier: NCT01267955|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2010
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Chondrosarcoma Dedifferentiated Chondrosarcoma Mesenchymal Chondrosarcoma Metastatic Chondrosarcoma Primary Central Chondrosarcoma||Other: Laboratory Biomarker Analysis Other: Pharmacogenomic Study Drug: Vismodegib||Phase 2|
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).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas|
|Actual Study Start Date :||December 21, 2010|
|Estimated Primary Completion Date :||June 30, 2018|
Experimental: Treatment (vismodegib)
Patients receive vismodegib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacogenomic Study
Other Name: PHARMACOGENOMICDrug: Vismodegib
- Clinical benefit (complete response + partial response + stable disease) rate per Response Evaluation Criteria in Solid Tumors criteria 2009 [ Time Frame: At 6 months ]At six months, patients will be classified as success (alive at 6 months AND complete response/partial response/stable disease) or failure (dead OR alive with progression).
- Progression-free survival [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years ]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 per Response Evaluation Criteria in Solid Tumors criteria 2009 [ Time Frame: Time from start of treatment to the time of death, assessed up to 3 years ]Overall survival 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: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years ]Will be described in responding subjects using descriptive statistics (median, extreme values, etc.).
- Mutational status of patched 1 and smoothened [ Time Frame: Baseline ]The 6-months clinical benefit rate will be correlated with the mutational status of patched and smoothened in order to identify predictive factors of clinical benefit from vismodegib.
- Expression pattern of hedgehog signaling molecules by using quantitative reverse transcription-polymerase chain reaction and immunohistochemistry [ Time Frame: Baseline ]The 6-months clinical benefit rate will be correlated with the expression score of hedgehog signaling molecules in order to identify predictive factors of clinical benefit from vismodegib.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267955
|Institut Bergonie Cancer Center|
|Bordeaux, France, 33076|
|Centre Oscar Lambert|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Hopital De La Timone|
|Marseille, France, 13385|
|Institut Curie Paris|
|Paris, France, 75005|
|Villejuif, France, 94805|
|Principal Investigator:||Antoine Italiano||Institut Bergonie Cancer Center|