Lapatinib in Stage IV Melanoma With ERBB4 Mutations

This study has been terminated.
(Protocol would not be able to reach stated accrual.)
Sponsor:
Information provided by (Responsible Party):
Udo Rudloff, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01264081
First received: December 18, 2010
Last updated: October 1, 2015
Last verified: October 2015
Results First Received: March 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Intervention: Drug: Lapatinib

  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
Thirty participants were registered, tested for the ERBB4 mutation, and taken off study as screening failures as they did not have the ERBB4 mutation to be treated with Lapatinib.

Reporting Groups
  Description
Group A Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.

Participant Flow for 3 periods

Period 1:   Participants Screened
    Group A  
STARTED     34  
COMPLETED     4  
NOT COMPLETED     30  
Screening failures                 30  

Period 2:   Started Treatment
    Group A  
STARTED     4  
COMPLETED     2  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Not complete cycle 1 due to death                 1  

Period 3:   Analysis
    Group A  
STARTED     2  
COMPLETED     2  
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
Group A Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.

Baseline Measures
    Group A  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     34  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  49  (0)  
Gender  
[units: participants]
 
Female     14  
Male     20  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     32  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     29  
More than one race     0  
Unknown or Not Reported     3  
Region of Enrollment  
[units: participants]
 
United States     34  



  Outcome Measures
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1.  Primary:   Number of Participants With a Partial Response (PR) and Complete Response (CR) to Lapatinib Who Have Metastatic Melanoma Harboring ERBB4 Mutations.   [ Time Frame: 3 years ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 3 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
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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: Dr. Udo Rudloff`
Organization: National Cancer Institute
phone: 301-496-3098
e-mail: rudloff@nih.gov


Publications:

Responsible Party: Udo Rudloff, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01264081     History of Changes
Other Study ID Numbers: 110048
11-C-0048
Study First Received: December 18, 2010
Results First Received: March 10, 2015
Last Updated: October 1, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration