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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Subjects who have received \ |
|
| Cohort B | Experimental | Subjects who have received >8 weeks of continuous treatment with GSK2118436 either as monotherapy or combination therapy with another approved anti-cancer agent |
|
| Cohort C | Experimental | Subjects who have received >8 weeks of continuous treatment with GSK2118436 in combination with a MEK inhibitor, GSK1120212 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2118436 | Drug | Study Drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Goodyear | Arizona | 85338 | United States | ||
| Novartis Investigative Site |
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| GSK1120212 |
| Drug |
Study Drug |
|
| Other approved anti-cancer agent | Drug | Study Drug |
|
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Novartis Investigative Site | Tucson | Arizona | 85724-5024 | United States |
| Novartis Investigative Site | Los Angeles | California | 90025 | United States |
| Novartis Investigative Site | Los Angeles | California | 90095-7059 | United States |
| Novartis Investigative Site | San Francisco | California | 94115 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34232 | United States |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109 | United States |
| Novartis Investigative Site | Detroit | Michigan | 48201 | United States |
| Novartis Investigative Site | Lebanon | New Hampshire | 03756 | United States |
| Novartis Investigative Site | New York | New York | 10016 | United States |
| Novartis Investigative Site | New York | New York | 10065 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43210 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19111 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Novartis Investigative Site | Greenville | South Carolina | 29605 | United States |
| Novartis Investigative Site | Memphis | Tennessee | 38120 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37232-5536 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84112 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | Randwick | New South Wales | 2031 | Australia |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | Heidelberg | Victoria | 3084 | Australia |
| Novartis Investigative Site | Melbourne | Victoria | 3004 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| Novartis Investigative Site | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Naples | Campania | 80131 | Italy |
| Novartis Investigative Site | Konin | 62-500 | Poland |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Seville | 41013 | Spain |
| Novartis Investigative Site | Headington | OX3 7LJ | United Kingdom |
| Novartis Investigative Site | London | W1G 6AD | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
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