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A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

Primary Purpose

Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK2118436

Dacarbazine (DTIC)

About this trial

This is an interventional treatment trial for Cancer focused on measuring Metastatic melanoma, melanoma, BRAF mutant, Advanced melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

GSK2118436

Dacarbazine (DTIC)

Crossover

Arm Description

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

Subjects will receive intravenous dacarbazine (DTIC) 1000 mg/m2 every 3 weeks

Subjects who initially receive DTIC will be allowed to receive GSK2118436 after initial progression.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) as Assessed by the Investigator

PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.

Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase

PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.

Secondary Outcome Measures

Overall Survival

Overall survival is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.

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

A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.

Number of Participants With a Best Overall Response of Confirmed CR or PR as Assessed by an Independent Radiologist: Randomized Phase

A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an independent radiologist per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.

Duration of Response as Assessed by the Investigator: Randomized Phase

Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.

Duration of Response as Assessed by an Independent Radiologist: Randomized Phase

Progression-free Survival (PFS2) as Assessed by the Investigator: Crossover Phase

PFS2 is defined as the time from the first dose of GSK2118436, in participants randomized to DTIC who crossed over to GSK2118436 after initial progression, to the earliest date of radiographic or photographic disease progression or death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.

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

Duration of Response as Assessed by the Investigator: Crossover Phase

Number of Participants With Non-melanoma Skin Lesions: Randomized Phase

Dermatological examinations were performed by the investigator, or at the discretion of the investigator, referred to a dermatologist. The number of participants with non-melanoma skin lessions was assessed from the time of Screening until study completion or discontinuation from the study for any reason.

Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay

Analytical and clinical validation of the companion diagnostic (cDx) assay was performed to determine the extent of agreement between the bioMerieux cDx assay (THxID BRAF Assay) and the Clinical Trial Assay (CTA) to detect BRAF mutations to determine participant eligibility into the study. Skin tissue samples collected at the Screening visit were used for this analysis. Multiple specimen per participant were analyzed.

Full Information

NCT ID

NCT01227889

First Posted

October 21, 2010

Last Updated

September 6, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01227889

Brief Title

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

December 23, 2010 (Actual)

Primary Completion Date

December 19, 2011 (Actual)

Study Completion Date

September 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer

Keywords

Metastatic melanoma, melanoma, BRAF mutant, Advanced melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

251 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK2118436

Arm Type

Experimental

Arm Description

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

Arm Title

Dacarbazine (DTIC)

Arm Type

Active Comparator

Arm Description

Subjects will receive intravenous dacarbazine (DTIC) 1000 mg/m2 every 3 weeks

Arm Title

Crossover

Arm Type

Experimental

Arm Description

Subjects who initially receive DTIC will be allowed to receive GSK2118436 after initial progression.

Intervention Type

Drug

Intervention Name(s)

GSK2118436

Intervention Description

150 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Dacarbazine (DTIC)

Intervention Description

Intravenous (IV), 1000 mg/m2 every 3 weeks until initial progression

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) as Assessed by the Investigator

Description

Time Frame

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)

Title

Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase

Description

PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.

Time Frame

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 Measure Information:

Title

Overall Survival

Description

Time Frame

Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)

Title

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

Description

Time Frame

From randomization until the first documented evidence of a confirmed complete response or partial response (median of 6.6 weeks)

Title

Number of Participants With a Best Overall Response of Confirmed CR or PR as Assessed by an Independent Radiologist: Randomized Phase

Description

A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an independent radiologist per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.

Time Frame

From randomization until the first documented evidence of a confirmed complete response or partial response (median of 12.0 weeks)

Title

Duration of Response as Assessed by the Investigator: Randomized Phase

Description

Time Frame

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)

Title

Duration of Response as Assessed by an Independent Radiologist: Randomized Phase

Description

Time Frame

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)

Title

Progression-free Survival (PFS2) as Assessed by the Investigator: Crossover Phase

Description

Time Frame

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)

Title

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

Description

Time Frame

From randomization until the first documented evidence of a confirmed complete response or partial response (up to 6.4 months)

Title

Duration of Response as Assessed by the Investigator: Crossover Phase

Description

Time Frame

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)

Title

Number of Participants With Non-melanoma Skin Lesions: Randomized Phase

Description

Time Frame

From Screening until study completion or discontinuation from the study (up to 9.9 months)

Title

Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay

Description

Time Frame

Screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35243

Country

United States

Facility Name

GSK Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

GSK Investigational Site

City

Vallejo

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

GSK Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

GSK Investigational Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

GSK Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

GSK Investigational Site

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

GSK Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

GSK Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

GSK Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

GSK Investigational Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

GSK Investigational Site

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

GSK Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Marseille Cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

GSK Investigational Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

GSK Investigational Site

City

Paris cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75006

Country

France

Facility Name

GSK Investigational Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

GSK Investigational Site

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

GSK Investigational Site

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

GSK Investigational Site

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91054

Country

Germany

Facility Name

GSK Investigational Site

City

Nuernberg

State/Province

Bayern

ZIP/Postal Code

90419

Country

Germany

Facility Name

GSK Investigational Site

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93053

Country

Germany

Facility Name

GSK Investigational Site

City

Kassel

State/Province

Hessen

ZIP/Postal Code

34125

Country

Germany

Facility Name

GSK Investigational Site

City

Wiesbaden

State/Province

Hessen

ZIP/Postal Code

65191

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30449

Country

Germany

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

GSK Investigational Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

GSK Investigational Site

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56068

Country

Germany

Facility Name

GSK Investigational Site

City

Ludwigshafen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67063

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Homburg

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

GSK Investigational Site

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

GSK Investigational Site

City

Erfurt

State/Province

Thueringen

ZIP/Postal Code

99089

Country

Germany

Facility Name

GSK Investigational Site

City

Gera

State/Province

Thueringen

ZIP/Postal Code

07548

Country

Germany

Facility Name

GSK Investigational Site

City

Jena

State/Province

Thueringen

ZIP/Postal Code

07740

Country

Germany

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

GSK Investigational Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

GSK Investigational Site

City

Gyor

ZIP/Postal Code

H-9024

Country

Hungary

Facility Name

GSK Investigational Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

GSK Investigational Site

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

GSK Investigational Site

City

Cork

Country

Ireland

Facility Name

GSK Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

GSK Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

GSK Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

GSK Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

GSK Investigational Site

City

Galway

ZIP/Postal Code

Co Galway

Country

Ireland

Facility Name

GSK Investigational Site

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41100

Country

Italy

Facility Name

GSK Investigational Site

City

Udine

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00144

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00167

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Rozzano (MI)

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

GSK Investigational Site

City

Siena

State/Province

Toscana

ZIP/Postal Code

53100

Country

Italy

Facility Name

GSK Investigational Site

City

Terni

State/Province

Umbria

ZIP/Postal Code

05100

Country

Italy

Facility Name

GSK Investigational Site

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Brzozow

ZIP/Postal Code

36-200

Country

Poland

Facility Name

GSK Investigational Site

City

Konin

ZIP/Postal Code

62-500

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-115

Country

Poland

Facility Name

GSK Investigational Site

City

Slupsk

ZIP/Postal Code

76-200

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

GSK Investigational Site

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

191104

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Stavropol

ZIP/Postal Code

355047

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Hospitalet de Llobregat, Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

GSK Investigational Site

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

22735384

Citation

Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, Rutkowski P, Blank CU, Miller WH Jr, Kaempgen E, Martin-Algarra S, Karaszewska B, Mauch C, Chiarion-Sileni V, Martin AM, Swann S, Haney P, Mirakhur B, Guckert ME, Goodman V, Chapman PB. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012 Jul 28;380(9839):358-65. doi: 10.1016/S0140-6736(12)60868-X. Epub 2012 Jun 25.

Results Reference

background

PubMed Identifier

31864178

Citation

Hauschild A, Ascierto PA, Schadendorf D, Grob JJ, Ribas A, Kiecker F, Dutriaux C, Demidov LV, Lebbe C, Rutkowski P, Blank CU, Gutzmer R, Millward M, Kefford R, Haas T, D'Amelio A Jr, Gasal E, Mookerjee B, Chapman PB. Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials. Eur J Cancer. 2020 Jan;125:114-120. doi: 10.1016/j.ejca.2019.10.033.

Results Reference

derived

PubMed Identifier

26446943

Citation

Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

Results Reference

derived

PubMed Identifier

26040620

Citation

Latimer NR, Abrams KR, Amonkar MM, Stapelkamp C, Swann RS. Adjusting for the Confounding Effects of Treatment Switching-The BREAK-3 Trial: Dabrafenib Versus Dacarbazine. Oncologist. 2015 Jul;20(7):798-805. doi: 10.1634/theoncologist.2014-0429. Epub 2015 Jun 3.

Results Reference

derived

PubMed Identifier

24769640

Citation

Grob JJ, Amonkar MM, Martin-Algarra S, Demidov LV, Goodman V, Grotzinger K, Haney P, Kampgen E, Karaszewska B, Mauch C, Miller WH Jr, Millward M, Mirakhur B, Rutkowski P, Chiarion-Sileni V, Swann S, Hauschild A. Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine. Ann Oncol. 2014 Jul;25(7):1428-1436. doi: 10.1093/annonc/mdu154. Epub 2014 Apr 25.

Results Reference

derived

PubMed Identifier

24408395

Citation

Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

Results Reference

derived

Learn more about this trial

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

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A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial