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BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation

This study has been completed.
Sponsor:
Collaborator:
Array BioPharma
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01894672
First received: July 3, 2013
Last updated: July 21, 2017
Last verified: May 2017
Results First Received: March 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: LGX818

  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
Protocol Open to Accrual 07/03/2013 Protocol Closed to Accrual 03/24/2015 Primary Completion Date 03/17/2016 Recruitment Location is the medical clinic

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
LGX818 Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.

Participant Flow:   Overall Study
    LGX818
STARTED   7 
COMPLETED   7 
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
LGX818 Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.

Baseline Measures
   LGX818 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  57.1% 
>=65 years      3  42.9% 
Age 
[Units: Years]
Median (Full Range)
 58 
 (53 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  28.6% 
Male      5  71.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Response According to RECIST v1.1 Criteria   [ Time Frame: 1.5 years ]

2.  Secondary:   Response Rate   [ Time Frame: 1.5 years ]

3.  Other Pre-specified:   Pharmacokinetic (PK) Analysis: Geometric Mean of Maximum Observed Concentration (Cmax) of LGX818 at Steady State   [ Time Frame: Cycle 1 - Day 1, 15; Cycle 2 - Day 15; Cycle 3 - Day 1, Day 15 ]

4.  Other Pre-specified:   Overall Survival   [ Time Frame: 1.5 years ]
Results not yet reported.   Anticipated Reporting Date:   03/2018  


  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
The protocol was stopped after 7 participants were accrued due to intolerable toxicities.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Paul Chapman MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4162
e-mail: chapmanp@MSKCC.ORG



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01894672     History of Changes
Other Study ID Numbers: 13-053
Study First Received: July 3, 2013
Results First Received: March 14, 2017
Last Updated: July 21, 2017