Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00669019
First received: April 26, 2008
Last updated: December 10, 2013
Last verified: December 2013
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Melanoma
Stage IIA Melanoma
Stage IIB Melanoma
Stage IIC Melanoma
Stage IV Melanoma
Intervention: Drug: saracatinib

  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
Patients were enrolled at five sites in the United States between August 2008 and September 2009.

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
Saracatinib Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Saracatinib  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     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
Saracatinib Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Saracatinib  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 25 to 80 )  
Gender  
[units: participants]
 
Female     8  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     23  
Performance Status [1]
[units: participants]
 
0     13  
1     10  
[1] ECOG performance status scores on a scale of 0-5, higher is worse



  Outcome Measures
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1.  Primary:   Objective Response Rate   [ Time Frame: Up to 25 weeks ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
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
Trial was designed with a maximum target accrual of 37 patients. The trial was stopped after the first stage per protocol based on the response rate among the first 23 patients.  


Results Point of Contact:  
Name/Title: Dr. Thomas F. Gajewski
Organization: University of Chicago
phone: 773-702-4601
e-mail: tgajewsk@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00669019     History of Changes
Other Study ID Numbers: NCI-2009-00193, N01CM62201, CDR0000594729, 16077A
Study First Received: April 26, 2008
Results First Received: December 10, 2013
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration