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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 26, 2007
Last Update Posted: June 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
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Reporting Groups
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 

  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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 3   4   7 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   1   4   5 
>=65 years   2   0   2 
[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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00563290     History of Changes
Other Study ID Numbers: NCI-2009-00226
NCI-2009-00226 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU 07070 ( Other Identifier: Ohio State University Medical Center )
7813 ( Other Identifier: CTEP )
P30CA016058 ( U.S. NIH Grant/Contract )
N01CM00070 ( U.S. NIH Grant/Contract )
First Submitted: November 22, 2007
First Posted: November 26, 2007
Results First Submitted: September 10, 2013
Results First Posted: March 20, 2015
Last Update Posted: June 18, 2015