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: May 6, 2014
Last verified: January 2014
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 175 mg oral, once daily 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 175 mg oral once daily 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

0 = Fully active, able to carry on all pre-disease performance without restriction

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours
  3. = Capable of only limited self-care, confined to bed/chair more than 50% of waking hours
  4. = Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair
  5. = Dead



  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


  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
Trial was designed with a maximum target accrual of 37 patients. Per protocol, the trial was stopped after the first stage based on an interim analysis of the response rate among the first 23 patients.


  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: 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: May 6, 2014
Health Authority: United States: Food and Drug Administration