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NCT01231594 · ClinicalTrials.gov registry record · Phase 1
A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
A Phase 1 study of Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 214
- Enrollment target
- 20
- Study locations
NCT01231594: Completed Phase 1 study of Cancer, sponsored by Novartis Pharmaceuticals.
NCT01231594 is a Phase 1 study of Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 214 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01231594, a Phase 1 study of Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 214 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG GSK2118436
- DRUG GSK1120212
- DRUG Other approved anti-cancer agent
Study Locations (20)
Arizona
- Novartis Investigative Site - Goodyear
- Novartis Investigative Site - Scottsdale
- Novartis Investigative Site - Tucson
California
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - San Francisco
Tennessee
- Novartis Investigative Site - Memphis
- Novartis Investigative Site - Nashville
- Novartis Investigative Site - Nashville
Michigan
- Novartis Investigative Site - Ann Arbor
- Novartis Investigative Site - Detroit
New York
- Novartis Investigative Site - New York
- Novartis Investigative Site - New York
Pennsylvania
- Novartis Investigative Site - Philadelphia
- Novartis Investigative Site - Pittsburgh
Florida
- Novartis Investigative Site - Sarasota
New Hampshire
- Novartis Investigative Site - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2010-11-05 |
| Est. Completion | 2018-04-09 |
| Phase | Phase 1 |
What the finished NCT01231594 record still lists
NCT01231594 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which GSK2118436 is the first listed.
NCT01231594 names 20 study sites across 11 states, led by Arizona, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01231594 about?
NCT01231594 is a clinical study titled "A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors". 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...
What is the current status of trial NCT01231594?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 214 participants. The study started on 2010-11-05. Estimated completion is 2018-04-09.
What conditions does trial NCT01231594 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT01231594?
The interventions under investigation include: GSK2118436 (DRUG), GSK1120212 (DRUG), Other approved anti-cancer agent (DRUG).
Who is sponsoring clinical trial NCT01231594?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01231594 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Michigan, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01231594's enrollment target sits among peer trials
214 223rd of 615 higher than 393 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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