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SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Pfizer
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00577382
First received: December 18, 2007
Last updated: October 16, 2016
Last verified: June 2016
Results First Received: August 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Mucosal Lentiginous Melanoma
Acral Lentiginous Malignant Melanoma
Intervention: Drug: Sunitinib

  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
The study, conducted at 7 medical centers, was activated on August 8, 2007 and closed on August 1, 2014. Patient enrollment to Cohort A occurred from September 2007 to January 2009 and Cohort B from March 2009 to June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial was amended in 2009 to revise sunitinib dosing due to difficulty with tolerability and evidence of progressive disease following treatment breaks. As such, there are two study cohorts: the first employing intermittent dosing of Sunitinib (Cohort A) and the second with continuous dosing (Cohort B).

Reporting Groups
  Description
Cohort A-Sunitinib Intermittent Dosing Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
Cohort B-Sunitinib Continuous Dosing Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.

Participant Flow:   Overall Study
    Cohort A-Sunitinib Intermittent Dosing   Cohort B-Sunitinib Continuous Dosing
STARTED   21   31 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   21   31 
Adverse Event                0                6 
Withdrawal by Subject                0                1 
Progressive Disease                17                19 
Intercurrent Illness                1                2 
Death                1                1 
Lost to Follow-up                2                2 
[1] Since treatment duration was not fixed, patients were not considered to have completed treatment.



  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.
The analysis dataset is comprised of treated patients.

Reporting Groups
  Description
Cohort A-Sunitinib Intermittent Dosing Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
Cohort B-Sunitinib Continuous Dosing Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Total Total of all reporting groups

Baseline Measures
   Cohort A-Sunitinib Intermittent Dosing   Cohort B-Sunitinib Continuous Dosing   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   31   52 
Age 
[Units: Years]
Median (Full Range)
 63 
 (38 to 80) 
 63 
 (40 to 86) 
 63 
 (38 to 86) 
Gender 
[Units: Participants]
     
Female   10   20   30 
Male   11   11   22 
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   3   3 
White   21   28   49 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   21   31   52 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   2-month Progression-free Survival Rate   [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months. ]

2.  Secondary:   Best Overall Response Rate   [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles. ]

3.  Secondary:   Overall Survival   [ Time Frame: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m). ]

4.  Secondary:   Time to Progression   [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles). ]


  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:  
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.


Results Point of Contact:  
Name/Title: F. Stephen Hodi, MD
Organization: Dana-Farber Cancer Institute
phone: 617.632.5053
e-mail: Stephen_Hodi@dfci.harvard.edu


Publications of Results:

Responsible Party: F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00577382     History of Changes
Other Study ID Numbers: 06-145
Study First Received: December 18, 2007
Results First Received: August 22, 2016
Last Updated: October 16, 2016