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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231594
• Other study ID #: 114144
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2010
• Est. completion date: April 9, 2018

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• GSK2118436
Study Drug
• GSK1120212
Study Drug
• Other approved anti-cancer agent
Study Drug

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Melbourne	Victoria
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	Randwick	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Lille
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Essen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Luebeck	Schleswig-Holstein
Italy	Novartis Investigative Site	Napoli	Campania
Poland	Novartis Investigative Site	Konin
Poland	Novartis Investigative Site	Warszawa
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Sevilla
United Kingdom	Novartis Investigative Site	Headington
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Ann Arbor	Michigan
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Goodyear	Arizona
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Lebanon	New Hampshire
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Francisco	California
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events, as a measure of safety and tolerability		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.