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Lapatinib in Stage IV Melanoma With ERBB4 Mutations

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ClinicalTrials.gov Identifier: NCT01264081
Recruitment Status : Terminated (Protocol would not be able to reach stated accrual.)
First Posted : December 21, 2010
Results First Posted : March 19, 2015
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Udo Rudloff, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Malignant Melanoma
Intervention: Drug: Lapatinib

  Participant Flow

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
Lapatinib 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
    Lapatinib
STARTED   34 
COMPLETED   4 
NOT COMPLETED   30 
Screening failures                30 

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

Period 3:   Analysis
    Lapatinib
STARTED   2 
COMPLETED   2 
NOT COMPLETED   0 



  Baseline Characteristics

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

Baseline Measures
   Lapatinib 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      34 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  41.2% 
Male      20  58.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   2.9% 
Not Hispanic or Latino      32  94.1% 
Unknown or Not Reported      1   2.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   2.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   2.9% 
White      29  85.3% 
More than one race      0   0.0% 
Unknown or Not Reported      3   8.8% 
Region of Enrollment 
[Units: Participants]
 
United States   34 


  Outcome Measures

1.  Primary:   Count 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:   Count of Participants With Adverse Events   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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 of Results:
Other 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
First Submitted: December 18, 2010
First Posted: December 21, 2010
Results First Submitted: March 10, 2015
Results First Posted: March 19, 2015
Last Update Posted: August 9, 2017