A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic... | NCT01227889 | Trialant

CompletedInterventionalPhase 3Updated Oct 4, 2017

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

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT01227889
Lead Sponsor: GlaxoSmithKlineINDUSTRY
Overall Status: Completed
Study Type: Interventional
Phase: Phase 3
Enrollment: 251Actual
Last Update Posted: Oct 4, 2017Actual
Start Date: Dec 23, 2010Actual
Primary Completion Date: Dec 19, 2011Actual
Completion Date: Sep 16, 2016Actual

Description

What the study is about and why it is being run, in the researchers' own words.

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
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.

Conditions

The medical conditions and diseases this study investigates.

Cancer

Interventions

The treatments and procedures being evaluated in this study.

GSK2118436
Dacarbazine (DTIC)

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

GSK Investigational Site

Birmingham, Alabama 35243, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: GlaxoSmithKlineINDUSTRY

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