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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01227889




Registration number
NCT01227889
Ethics application status
Date submitted
21/10/2010
Date registered
25/10/2010
Date last updated
4/10/2017

Titles & IDs
Public title
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Scientific title
A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Secondary ID [1] 0 0
113683
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 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
Treatment: Drugs - Dacarbazine (DTIC)

Experimental: GSK2118436 - Subjects in this arm will receive GSK2118436 150 mg twice daily.

Active comparator: Dacarbazine (DTIC) - Subjects will receive intravenous dacarbazine (DTIC) 1000 mg/m2 every 3 weeks

Experimental: Crossover - Subjects who initially receive DTIC will be allowed to receive GSK2118436 after initial progression.


Treatment: Drugs: GSK2118436
150 mg twice daily

Treatment: Drugs: Dacarbazine (DTIC)
Intravenous (IV), 1000 mg/m2 every 3 weeks until initial progression
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by the Investigator
Timepoint [1] 0 0
Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)
Primary outcome [2] 0 0
Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase
Timepoint [2] 0 0
Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)
Secondary outcome [2] 0 0
Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Randomized Phase
Timepoint [2] 0 0
From randomization until the first documented evidence of a confirmed complete response or partial response (median of 6.6 weeks)
Secondary outcome [3] 0 0
Number of Participants With a Best Overall Response of Confirmed CR or PR as Assessed by an Independent Radiologist: Randomized Phase
Timepoint [3] 0 0
From randomization until the first documented evidence of a confirmed complete response or partial response (median of 12.0 weeks)
Secondary outcome [4] 0 0
Duration of Response as Assessed by the Investigator: Randomized Phase
Timepoint [4] 0 0
Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 65.6 weeks)
Secondary outcome [5] 0 0
Duration of Response as Assessed by an Independent Radiologist: Randomized Phase
Timepoint [5] 0 0
Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 7.4 months)
Secondary outcome [6] 0 0
Progression-free Survival (PFS2) as Assessed by the Investigator: Crossover Phase
Timepoint [6] 0 0
Time from first dose of GSK2118436 in participants who crossover after initial progression to the earliest date of radiographical or photographical PD or death due to any cause (up to 6.4 months)
Secondary outcome [7] 0 0
Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Crossover Phase
Timepoint [7] 0 0
From randomization until the first documented evidence of a confirmed complete response or partial response (up to 6.4 months)
Secondary outcome [8] 0 0
Duration of Response as Assessed by the Investigator: Crossover Phase
Timepoint [8] 0 0
Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 6.4 months)
Secondary outcome [9] 0 0
Number of Participants With Non-melanoma Skin Lesions: Randomized Phase
Timepoint [9] 0 0
From Screening until study completion or discontinuation from the study (up to 9.9 months)
Secondary outcome [10] 0 0
Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay
Timepoint [10] 0 0
Screening

Eligibility
Key inclusion criteria
* Adults at least 18 years of age
* Has advanced (unresectable Stage III) or metastatic (Stage IV) melanoma that is BRAF mutation positive (V600E)
* Is treatment naive for advanced (unresectable) or metastatic melanoma, with the exception of Interleukin 2 (IL-2) which is allowed.
* Has measurable disease according to RECIST 1.1 criteria.
* 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 adequate organ function.
* Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
* Evidence of active central nervous system (CNS) disease.
* Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
* A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* History of Human Immunodeficiency Virus (HIV) infection.
* Certain cardiac abnormalities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Crossover
Other design features
Phase
Phase 3
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
23/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/09/2016
Sample size
Target
Accrual to date
Final
251
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [2] 0 0
GSK Investigational Site - Southport
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Marseille Cedex 5
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
France
State/province [16] 0 0
Paris cedex 18
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Reims
Country [19] 0 0
France
State/province [19] 0 0
Villejuif
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-Wuerttemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Bayern
Country [22] 0 0
Germany
State/province [22] 0 0
Hessen
Country [23] 0 0
Germany
State/province [23] 0 0
Niedersachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-Westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Rheinland-Pfalz
Country [26] 0 0
Germany
State/province [26] 0 0
Saarland
Country [27] 0 0
Germany
State/province [27] 0 0
Sachsen-Anhalt
Country [28] 0 0
Germany
State/province [28] 0 0
Schleswig-Holstein
Country [29] 0 0
Germany
State/province [29] 0 0
Thueringen
Country [30] 0 0
Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Hungary
State/province [31] 0 0
Debrecen
Country [32] 0 0
Hungary
State/province [32] 0 0
Gyor
Country [33] 0 0
Hungary
State/province [33] 0 0
Miskolc
Country [34] 0 0
Hungary
State/province [34] 0 0
Pecs
Country [35] 0 0
Ireland
State/province [35] 0 0
Cork
Country [36] 0 0
Ireland
State/province [36] 0 0
Dublin
Country [37] 0 0
Ireland
State/province [37] 0 0
Galway
Country [38] 0 0
Italy
State/province [38] 0 0
Emilia-Romagna
Country [39] 0 0
Italy
State/province [39] 0 0
Friuli-Venezia-Giulia
Country [40] 0 0
Italy
State/province [40] 0 0
Lazio
Country [41] 0 0
Italy
State/province [41] 0 0
Liguria
Country [42] 0 0
Italy
State/province [42] 0 0
Lombardia
Country [43] 0 0
Italy
State/province [43] 0 0
Toscana
Country [44] 0 0
Italy
State/province [44] 0 0
Umbria
Country [45] 0 0
Italy
State/province [45] 0 0
Veneto
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Poland
State/province [47] 0 0
Brzozow
Country [48] 0 0
Poland
State/province [48] 0 0
Konin
Country [49] 0 0
Poland
State/province [49] 0 0
Krakow
Country [50] 0 0
Poland
State/province [50] 0 0
Slupsk
Country [51] 0 0
Poland
State/province [51] 0 0
Warszawa
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Kazan
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Moscow
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Ryazan
Country [55] 0 0
Russian Federation
State/province [55] 0 0
St. Petersburg
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Stavropol
Country [57] 0 0
Spain
State/province [57] 0 0
Badalona
Country [58] 0 0
Spain
State/province [58] 0 0
Barcelona
Country [59] 0 0
Spain
State/province [59] 0 0
Hospitalet de Llobregat, Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Pamplona
Country [62] 0 0
Spain
State/province [62] 0 0
Sevilla

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/NCT01227889