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. |
| ClinicalTrials.gov Identifier: NCT01231594 |
|
Recruitment Status :
Completed
First Posted : November 1, 2010
Last Update Posted : March 22, 2019
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 :
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT01231594
Locations
| 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 | |
| France | |
| Novartis Investigative Site | |
| Lille, France, 59037 | |
| Germany | |
| Novartis Investigative Site | |
| Essen, Nordrhein-Westfalen, Germany, 45122 | |
| Novartis Investigative Site | |
| Luebeck, Schleswig-Holstein, Germany, 23538 | |
| Novartis Investigative Site | |
| Berlin, Germany, 10117 | |
| Italy | |
| Novartis Investigative Site | |
| Napoli, Campania, Italy, 80131 | |
| Poland | |
| Novartis Investigative Site | |
| Konin, Poland, 62-500 | |
| Novartis Investigative Site | |
| Warszawa, Poland, 02-781 | |
| Spain | |
| 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
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov 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 |
| 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 Cancer Safety GSK2118436 BRAF mutation positive tumors |
Additional relevant MeSH terms:
|
Trametinib Dabrafenib Antineoplastic Agents |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |