Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
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|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: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859937
|Principal Investigator:||Stuart Wong||University of Chicago Comprehensive Cancer Center|