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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

NCT ID: NCT01227889

Last Updated: 2017-10-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-23

Study Completion Date

2016-09-16

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK2118436

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

Group Type EXPERIMENTAL

GSK2118436

Intervention Type DRUG

150 mg twice daily

Dacarbazine (DTIC)

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

Group Type ACTIVE_COMPARATOR

Dacarbazine (DTIC)

Intervention Type DRUG

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

Crossover

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

Group Type EXPERIMENTAL

GSK2118436

Intervention Type DRUG

150 mg twice daily

Interventions

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GSK2118436

150 mg twice daily

Intervention Type DRUG

Dacarbazine (DTIC)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Mobile, Alabama, United States

Site Status

GSK Investigational Site

La Jolla, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

San Francisco, California, United States

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GSK Investigational Site

Vallejo, California, United States

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GSK Investigational Site

Orlando, Florida, United States

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GSK Investigational Site

Indianapolis, Indiana, United States

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GSK Investigational Site

Ann Arbor, Michigan, United States

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GSK Investigational Site

Lebanon, New Hampshire, United States

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GSK Investigational Site

New York, New York, United States

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GSK Investigational Site

Westmead, New South Wales, Australia

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GSK Investigational Site

Southport, Queensland, Australia

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GSK Investigational Site

Adelaide, South Australia, Australia

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GSK Investigational Site

Nedlands, Western Australia, Australia

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GSK Investigational Site

Edmonton, Alberta, Canada

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GSK Investigational Site

Kelowna, British Columbia, Canada

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GSK Investigational Site

Toronto, Ontario, Canada

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GSK Investigational Site

Toronto, Ontario, Canada

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GSK Investigational Site

Montreal, Quebec, Canada

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GSK Investigational Site

Bordeaux, , France

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GSK Investigational Site

Lille, , France

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GSK Investigational Site

Marseille, , France

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GSK Investigational Site

Nice, , France

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Paris, , France

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GSK Investigational Site

Paris, , France

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GSK Investigational Site

Reims, , France

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Villejuif, , France

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GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

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GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

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GSK Investigational Site

Erlangen, Bavaria, Germany

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GSK Investigational Site

Nuremberg, Bavaria, Germany

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GSK Investigational Site

Regensburg, Bavaria, Germany

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GSK Investigational Site

Kassel, Hesse, Germany

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GSK Investigational Site

Wiesbaden, Hesse, Germany

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GSK Investigational Site

Hanover, Lower Saxony, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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GSK Investigational Site

Koblenz, Rhineland-Palatinate, Germany

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GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

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GSK Investigational Site

Homburg, Saarland, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

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Kiel, Schleswig-Holstein, Germany

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Erfurt, Thuringia, Germany

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Gera, Thuringia, Germany

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Jena, Thuringia, Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Miskolc, , Hungary

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Pécs, , Hungary

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Cork, , Ireland

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GSK Investigational Site

Dublin, , Ireland

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GSK Investigational Site

Dublin, , Ireland

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GSK Investigational Site

Dublin, , Ireland

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GSK Investigational Site

Dublin, , Ireland

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GSK Investigational Site

Galway, , Ireland

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GSK Investigational Site

Modena, Emilia-Romagna, Italy

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GSK Investigational Site

Udine, Friuli Venezia Giulia, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Genoa, Liguria, Italy

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GSK Investigational Site

Rozzano (MI), Lombardy, Italy

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GSK Investigational Site

Siena, Tuscany, Italy

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GSK Investigational Site

Terni, Umbria, Italy

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GSK Investigational Site

Padua, Veneto, Italy

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GSK Investigational Site

Amsterdam, , Netherlands

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GSK Investigational Site

Brzozów, , Poland

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GSK Investigational Site

Konin, , Poland

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Krakow, , Poland

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GSK Investigational Site

Słupsk, , Poland

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GSK Investigational Site

Warsaw, , Poland

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GSK Investigational Site

Kazan', , Russia

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GSK Investigational Site

Moscow, , Russia

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GSK Investigational Site

Ryazan, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Stavropol, , Russia

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GSK Investigational Site

Badalona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Hospitalet de Llobregat, Barcelona, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Pamplona, , Spain

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GSK Investigational Site

Seville, , Spain

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Countries

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United States Australia Canada France Germany Hungary Ireland Italy Netherlands Poland Russia Spain

References

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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.

Reference Type BACKGROUND
PMID: 22735384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31864178 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26446943 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26040620 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24769640 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24408395 (View on PubMed)

Other Identifiers

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113683

Identifier Type: -

Identifier Source: org_study_id