Status:
COMPLETED
A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT01231594
Start Date
November 5 2010
End Date
April 9 2018
Last Update
March 22 2019
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Goodyear, Arizona, United States, 85338
2
Novartis Investigative Site
Scottsdale, Arizona, United States, 85259
3
Novartis Investigative Site
Tucson, Arizona, United States, 85724-5024
4
Novartis Investigative Site
Los Angeles, California, United States, 90025