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A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation (TEAM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028222
First Posted: December 9, 2009
Last Update Posted: December 30, 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):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: October 23, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Melanoma
Interventions: Drug: Nilotinib
Drug: DTIC

  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
No text entered.

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
Nilotinib 400 mg twice daily
DTIC 850 mg/m2 IV every 3 weeks

Participant Flow:   Overall Study
    Nilotinib   DTIC
STARTED   42   13 
Cross Over From DTIC to Nilotinib   0   10 
COMPLETED   4   0 
NOT COMPLETED   38   13 
Protocol deviation                1                0 
Disease progression                33                9 
Administrative problems                1                1 
Lost to Follow-up                0                1 
Withdrawal by Subject                1                0 
Crossover to nilotinib w/out progression                0                2 
Adverse Event                2                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
Nilotinib 400 mg twice daily
DTIC 850 mg/m2 IV every 3 weeks
Total Total of all reporting groups

Baseline Measures
   Nilotinib   DTIC   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   13   55 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (12.39)   68.8  (12.99)   66.8  (12.69) 
Gender 
[Units: Participants]
     
Female   23   8   31 
Male   19   5   24 


  Outcome Measures
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1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: End of study (up to 39 months) ]

2.  Secondary:   Durable Overall Response Rate (DORR)   [ Time Frame: End of study (up to 39 months) ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: End of study (up to 39 months) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: End of study (up to 39 months) ]

5.  Secondary:   Time to Objective Response (TOR)   [ Time Frame: End of study (up to 39 months) ]

6.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: End of study (up to 39 months) ]

7.  Secondary:   PFS Rate   [ Time Frame: End of study (up to 39 months) ]

8.  Secondary:   OS Rate   [ Time Frame: End of study (up to 39 months) ]


  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 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Novartis
Organization: Study Director
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01028222     History of Changes
Other Study ID Numbers: CAMN107B2301
2009-015514-21 ( EudraCT Number )
First Submitted: December 7, 2009
First Posted: December 9, 2009
Results First Submitted: October 23, 2015
Results First Posted: November 26, 2015
Last Update Posted: December 30, 2015