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Trial record 1 of 1 for:    NCT01820364
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LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma (LOGIC)

This study has been terminated.
(Study was withdrawn due to scientific and business considerations.)
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01820364
First received: March 25, 2013
Last updated: November 10, 2016
Last verified: November 2016
Results First Received: April 13, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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

The study began on 04-Nov-2013 (First Subject First Visit) to the CLGX818X2102 (LOGIC 1) study. A total of 15 subjects were enrolled. The last subject's last visit occurred on 23-Mar-2015.

Not completed subjects represents subjects that stopped treatment early, due to the corresponding reason.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

After careful evaluation of slow enrollment and the BRAF-mutant melanoma treatment landscape, recruitment was permanently halted on 26-Jul-2014.

This recruitment halt was not a consequence of any safety concern and patients who were ongoing in the study continued to be treated as per protocol.


Reporting Groups
  Description
Part I: LGX818 - Single Agent Subjects in Part I of the study received LGX818 as a single agent.
Part II: CLGX818 + MEK162 As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.

Participant Flow for 2 periods

Period 1:   Part I: LGX818
    Part I: LGX818 - Single Agent   Part II: CLGX818 + MEK162
STARTED   15   0 
COMPLETED   1   0 
NOT COMPLETED   14   0 
Death                1                0 
Administrative Problems                3                0 
Adverse Event                6                0 
Disease Progression                4                0 

Period 2:   Part II: LGX818 + MEK162
    Part I: LGX818 - Single Agent   Part II: CLGX818 + MEK162
STARTED   0   1 
COMPLETED   0   0 
NOT COMPLETED   0   1 
Study Termination                0                1 



  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 population for Baseline Demographics is composed of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.

Reporting Groups
  Description
Part I: LGX818 - Single Agent Subjects in Part I of the study received LGX818 as a single agent.

Baseline Measures
   Part I: LGX818 - Single Agent 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      12  80.0% 
>=65 years      3  20.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.3  (16.53) 
Gender 
[Units: Participants]
Count of Participants
 
Female      7  46.7% 
Male      8  53.3% 
Region of Enrollment 
[Units: Participants]
 
United States   2 
Australia   3 
Switzerland   6 
Germany   1 
Spain   3 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 80.3  (19.11) 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 171.8  (9.51) 
WHO/ ECOG performance status [1] 
[Units: Participants]
 
 14 
 1 
[1]

Categories:

  • 0 - Fully active, able to carry on all pre-disease performance without restriction
  • 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  • 2 - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  • 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
  • 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair


  Outcome Measures
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1.  Primary:   Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)   [ Time Frame: Baseline through study completion (approximately 2 years) ]

2.  Secondary:   Incidence of Dose Limiting Toxicities (DLTs) (Part II)   [ Time Frame: Baseline through study completion (approximately 2 years) ]

3.  Secondary:   Plasma Concentration and Derived Pharmacokinetic Parameters   [ Time Frame: Baseline through study completion (approximately 2 years) ]

4.  Secondary:   Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I)   [ Time Frame: Baseline through completion of Part I of the study (approximately 2 years) ]

5.  Secondary:   Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II)   [ Time Frame: Entry to Part II of the study through study completion (approximately 22 days) ]

6.  Secondary:   Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways   [ Time Frame: Baseline and at progression with LGX818 single agent treatment ]


  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
Recruitment halted on 26-Jul-2014, which led to small numbers of subjects analyzed. This recruitment halt was not a consequence of any safety concern and patients who were ongoing in the study continued to be treated as per protocol.


  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: Study Director
Organization: Array BioPharma, Inc.
phone: 303-381-6604
e-mail: clinicaltrials@arraybiopharma.com



Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01820364     History of Changes
Other Study ID Numbers: CLGX818X2102
2012-004798-17 ( EudraCT Number )
Study First Received: March 25, 2013
Results First Received: April 13, 2016
Last Updated: November 10, 2016