Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
|ClinicalTrials.gov Identifier: NCT00859937|
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : April 3, 2015
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Salivary Gland Neoplasm Recurrent Salivary Gland Carcinoma Salivary Gland Adenoid Cystic Carcinoma Stage IV Major Salivary Gland Cancer AJCC v7||Drug: Dasatinib Other: Laboratory Biomarker Analysis||Phase 2|
I. Determine the objective response rate (complete response plus partial response) of dasatinib in adenoid cystic carcinoma (ACC).
II. Determine the progression-free survival of dasatinib in ACC.
I. Determine the duration of response. II. Determine the stable disease rate and duration of stable disease. III. Determine progression-free survival. IV. Determine the median survival. V. Determine the overall survival. VI. Determine the safety and tolerability.
I. To examine biomarkers that relate to SRC proto-oncogene, non-receptor tyrosine kinase (Src) signal transduction and to correlate these biomarkers with clinical response to dasatinib in ACC and non-ACC malignant salivary gland tumors (MSGT).
II. Determine if activating mutations in platelet-derived growth factor alpha polypeptide (PDGFA) and KIT are associated with response in ACC.
Patients receive dasatinib orally (PO) twice daily (BID) 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 at 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Dasatinib (BMS 354825) for Recurrent or Metastatic c-KIT Expressing Adenoid Cystic Carcinoma and Non-adenoid Cystic Malignant Salivary Tumors|
|Actual Study Start Date :||March 16, 2009|
|Actual Primary Completion Date :||January 30, 2013|
Experimental: Arm I
Patients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
- Response Rate [ Time Frame: Up to 2 months ]Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
- Progression-free Survival [ Time Frame: up to 5 years ]Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.
- Overall Survival [ Time Frame: Up to 5 years ]Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.
- Changes in Laboratory Correlates [ Time Frame: Baseline and 4 weeks ]Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859937
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|Principal Investigator:||Stuart Wong||University of Chicago Comprehensive Cancer Center|