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

March 20, 2019 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Novartis Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Novartis Investigative Site
      • Melbourne, Victoria, Australia, 3004
        • Novartis Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
  • France
      • Lille, France, 59037
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • Novartis Investigative Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Novartis Investigative Site
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Novartis Investigative Site
  • Poland
      • Konin, Poland, 62-500
        • Novartis Investigative Site
      • Warszawa, Poland, 02-781
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Sevilla, Spain, 41013
        • Novartis Investigative Site
  • United Kingdom
      • Headington, United Kingdom, OX3 7LJ
        • Novartis Investigative Site
      • London, United Kingdom, W1G 6AD
        • Novartis Investigative Site
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Novartis Investigative Site
      • Scottsdale, Arizona, United States, 85259
        • Novartis Investigative Site
      • Tucson, Arizona, United States, 85724-5024
        • Novartis Investigative Site
    • California
      • 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
        • Novartis Investigative Site
    • Florida
      • Sarasota, Florida, United States, 34232
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Novartis Investigative Site
      • Detroit, Michigan, United States, 48201
        • Novartis Investigative Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10016
        • Novartis Investigative Site
      • New York, New York, United States, 10065
        • Novartis Investigative Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Novartis Investigative Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Novartis Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37203
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37232-5536
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Novartis Investigative Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 5, 2010

Primary Completion (ACTUAL)

April 9, 2018

Study Completion (ACTUAL)

April 9, 2018

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (ESTIMATE)

November 1, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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