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Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01092728
First received: March 23, 2010
Last updated: July 20, 2016
Last verified: July 2016
Results First Received: May 13, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: Dasatinib
Procedure: Surgical Resection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: March 2011 to September 2013. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 19 participants were enrolled, out of which 18 participants were included in the analysis and 1 participant was a screen failure.

Reporting Groups
  Description
Dasatinib + Completely Resectable Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Dasatinib + Unresectable Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).

Participant Flow:   Overall Study
    Dasatinib + Completely Resectable     Dasatinib + Unresectable  
STARTED     4     14  
COMPLETED     0     0  
NOT COMPLETED     4     14  
Withdrawal by Subject                 2                 0  
Adverse Event                 0                 1  
Disease Progression                 1                 13  
Prohibited Concomitant Medications                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One participant was screen-failed prior to study group entry.

Reporting Groups
  Description
Dasatinib + Completely Resectable Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Dasatinib + Unresectable Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Total Total of all reporting groups

Baseline Measures
    Dasatinib + Completely Resectable     Dasatinib + Unresectable     Total  
Number of Participants  
[units: participants]
  4     14     18  
Age  
[units: years]
Median (Full Range)
  76  
  (74 to 81)  
  66  
  (43 to 79)  
  71  
  (43 to 81)  
Gender  
[units: participants]
     
Female     2     10     12  
Male     2     4     6  
Region of Enrollment  
[units: participants]
     
United States     4     14     18  



  Outcome Measures
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1.  Primary:   Biologic Response Evaluation of Tumors With and Without Resectable Tumors   [ Time Frame: Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards ]

2.  Secondary:   Progression-Free Survival   [ Time Frame: Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kevin Kim, MD/Melanoma Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 1-877-MDA-6789
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01092728     History of Changes
Other Study ID Numbers: 2009-0447
NCI-2011-00468 ( Registry Identifier: NCI CTRP )
Study First Received: March 23, 2010
Results First Received: May 13, 2016
Last Updated: July 20, 2016
Health Authority: United States: Institutional Review Board