Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00563290
First received: November 22, 2007
Last updated: March 18, 2015
Last verified: March 2015
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Skin Cancer
Squamous Cell Carcinoma of the Skin
Stage 0 Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Interventions: Drug: dasatinib
Other: laboratory biomarker analysis

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I Dasatinib Patients receive 100 mg orally twice a day.
Arm II Dasatinib Patients receive 70 mg dasatinib PO BID on days 1-28

Participant Flow:   Overall Study
    Arm I Dasatinib     Arm II Dasatinib  
STARTED     3     4  
COMPLETED     3     4  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Arm I Dasatinib Patients receive oral dasatinib 100 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II Dastinib Patients receive oral dasatinib 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Arm I Dasatinib     Arm II Dastinib     Total  
Number of Participants  
[units: participants]
  3     4     7  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     4     5  
>=65 years     2     0     2  
Gender  
[units: participants]
     
Female     1     2     3  
Male     2     2     4  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     3     4     7  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Objective Response Rate (Complete Response and Partial Response)   [ Time Frame: Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Time from start of treatment to time of progression, assessed up to 12 weeks ]

3.  Secondary:   Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)   [ Time Frame: At baseline ]

4.  Secondary:   COX-2 Presence by IHC   [ Time Frame: At baseline ]


  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
3 patients were treated with Dasatinib 100 mg PO twice daily and 4 patients were treated with Daatinib 70 mg PO twice daily.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas Olencki, DO
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-2886
e-mail: Thomas.Olencki@osumc.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00563290     History of Changes
Other Study ID Numbers: NCI-2009-00226, NCI-2009-00226, CDR0000576527, OSU-07070, OSU 07070, 7813, P30CA016058, N01CM00070
Study First Received: November 22, 2007
Results First Received: September 10, 2013
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration