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A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231594
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : March 22, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator.

Condition or disease Intervention/treatment Phase
Cancer Drug: GSK2118436 Drug: GSK1120212 Drug: Other approved anti-cancer agent Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
Actual Study Start Date : November 5, 2010
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dabrafenib

Arm Intervention/treatment
Experimental: Cohort A
Subjects who have received </= 8 weeks of GSK2118436 monotherapy in the parent study
Drug: GSK2118436
Study Drug

Experimental: Cohort B
Subjects who have received >8 weeks of continuous treatment with GSK2118436 either as monotherapy or combination therapy with another approved anti-cancer agent
Drug: GSK2118436
Study Drug

Drug: Other approved anti-cancer agent
Study Drug

Experimental: Cohort C
Subjects who have received >8 weeks of continuous treatment with GSK2118436 in combination with a MEK inhibitor, GSK1120212
Drug: GSK2118436
Study Drug

Drug: GSK1120212
Study Drug

Primary Outcome Measures :
  1. Number of participants with adverse events, as a measure of safety and tolerability [ Time Frame: From date of transition into this Rollover study until 28 days following the last dose. Subjects may continue to receive study medication until disease progression, death or unacceptable adverse event; there is no time limit for this outcome measure. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has provided signed written informed consent for this study
  • Has demonstrated compliance with study drug(s), treatment visit schedules, and the requirements and restrictions listed in the consent form
  • Is currently participating in a GSK-sponsored study of GSK2118436
  • Currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with GSK2118436 (either as monotherapy or as part of a combination treatment regimen)
  • For Cohort C only: Subjects must have a calcium phosphate product (CPP) of <4.4 mmol^2/L^2 (55 mg^2/dL^2) if they are to continue treatment with GSK1120212
  • Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
  • Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with GSK2118436
  • Women of childbearing potential must have a negative serum pregnancy test at the time of transition to this study and before the first dose of study treatment
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Exclusion Criteria:

  • Permanent discontinuation of GSK2118436 in the parent study due to toxicity or disease progression
  • Local access to commercially available GSK2118436
  • Currently receiving treatment with any prohibited medication(s)
  • Any unresolved toxicity > Grade 2 (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical Monitor
  • Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to this study that may interfere with assessment of toxicity
  • Presence of rheumatoid arthritis
  • Corrected QT (QTc) interval >/= 480 msec at the time of transition to this study
  • Left ventricular ejection fraction (LVEF) </= institutional lower limit of normal (LLN) by ECHO at the time of transition to this study
  • Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system at the time of transition to this study
  • Pregnant or lactating female
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01231594

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United States, Arizona
Novartis Investigative Site
Goodyear, Arizona, United States, 85338
Novartis Investigative Site
Scottsdale, Arizona, United States, 85259
Novartis Investigative Site
Tucson, Arizona, United States, 85724-5024
United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90025
Novartis Investigative Site
Los Angeles, California, United States, 90095-7059
Novartis Investigative Site
San Francisco, California, United States, 94115
United States, Florida
Novartis Investigative Site
Sarasota, Florida, United States, 34232
United States, Michigan
Novartis Investigative Site
Ann Arbor, Michigan, United States, 48109
Novartis Investigative Site
Detroit, Michigan, United States, 48201
United States, New Hampshire
Novartis Investigative Site
Lebanon, New Hampshire, United States, 03756
United States, New York
Novartis Investigative Site
New York, New York, United States, 10016
Novartis Investigative Site
New York, New York, United States, 10065
United States, Ohio
Novartis Investigative Site
Columbus, Ohio, United States, 43210
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19111
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Novartis Investigative Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Novartis Investigative Site
Memphis, Tennessee, United States, 38120
Novartis Investigative Site
Nashville, Tennessee, United States, 37203
Novartis Investigative Site
Nashville, Tennessee, United States, 37232-5536
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75246
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
San Antonio, Texas, United States, 78229
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84112
United States, Washington
Novartis Investigative Site
Tacoma, Washington, United States, 98405
Australia, New South Wales
Novartis Investigative Site
Randwick, New South Wales, Australia, 2031
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Novartis Investigative Site
Heidelberg, Victoria, Australia, 3084
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site
Lille, France, 59037
Novartis Investigative Site
Essen, Nordrhein-Westfalen, Germany, 45122
Novartis Investigative Site
Luebeck, Schleswig-Holstein, Germany, 23538
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Napoli, Campania, Italy, 80131
Novartis Investigative Site
Konin, Poland, 62-500
Novartis Investigative Site
Warszawa, Poland, 02-781
Novartis Investigative Site
Barcelona, Spain, 08035
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Sevilla, Spain, 41013
United Kingdom
Novartis Investigative Site
Headington, United Kingdom, OX3 7LJ
Novartis Investigative Site
London, United Kingdom, W1G 6AD
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01231594    
Other Study ID Numbers: 114144
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
BRAF Inhibitor
BRAF mutation positive tumors
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action