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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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