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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01153763




Registration number
NCT01153763
Ethics application status
Date submitted
27/05/2010
Date registered
30/06/2010
Date last updated
27/09/2017

Titles & IDs
Public title
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Scientific title
A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Secondary ID [1] 0 0
113710
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK2118436

Other: All patients - Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.


Treatment: Drugs: GSK2118436
Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [1] 0 0
Number of Participants With a Best Overall Response of CR or PR as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [2] 0 0
Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation
Timepoint [2] 0 0
Up to 60 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
Timepoint [3] 0 0
Up to 60 months
Secondary outcome [4] 0 0
Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation
Timepoint [4] 0 0
Up to 60 months
Secondary outcome [5] 0 0
Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation
Timepoint [5] 0 0
Up to 60 months
Secondary outcome [6] 0 0
Overall Survival for Participants Who Had a BRAF V600E Mutation
Timepoint [6] 0 0
Up to 60 months
Secondary outcome [7] 0 0
Overall Survival for Participants Who Had a BRAF V600K Mutation
Timepoint [7] 0 0
From the first dose to death due to any cause (up to 60 months)
Secondary outcome [8] 0 0
Number of Participants With AEs and Serious Adverse Events (SAEs)
Timepoint [8] 0 0
Up to 60 months
Secondary outcome [9] 0 0
Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades
Timepoint [9] 0 0
Up to 60 months
Secondary outcome [10] 0 0
Number of Participants With Change From Baseline in Temperature and Pulse Rate
Timepoint [10] 0 0
Up to 60 months
Secondary outcome [11] 0 0
Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timepoint [11] 0 0
Up to 60 months
Secondary outcome [12] 0 0
Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels
Timepoint [12] 0 0
Up to 60 months

Eligibility
Key inclusion criteria
* Must be at least 18 years of age
* Must have histologically confirmed cutaneous metastatic melanoma (Stage IV) that is BRAF mutation-positive (V600 E/K) as determined via central testing with a BRAF mutation assay.
* Is treatment naive or has received prior treatment for metastatic melanoma.
* Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment.
* Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
* Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
* Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with a BRAF or MEK inhibitor.
* Cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of GSK2118436.
* A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
* History or evidence of brain metastases on MRI or head CT if MRI is not able to be performed.
* History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Certain cardiac abnormalities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Newcastle
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2300 - Newcastle
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
France
State/province [5] 0 0
Bordeaux
Country [6] 0 0
France
State/province [6] 0 0
Boulogne-Billancourt
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Marseille Cedex 5
Country [9] 0 0
France
State/province [9] 0 0
Montpellier
Country [10] 0 0
France
State/province [10] 0 0
Paris Cedex 10
Country [11] 0 0
France
State/province [11] 0 0
Villejuif
Country [12] 0 0
Germany
State/province [12] 0 0
Nordrhein-Westfalen
Country [13] 0 0
Germany
State/province [13] 0 0
Schleswig-Holstein
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Italy
State/province [15] 0 0
Campania
Country [16] 0 0
Italy
State/province [16] 0 0
Liguria
Country [17] 0 0
Italy
State/province [17] 0 0
Veneto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01153763