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NCT01954043 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors
A Phase 1 study of Cancer, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 6
- Study locations
NCT01954043: Completed Phase 1 study of Cancer, sponsored by GlaxoSmithKline.
NCT01954043 is a Phase 1 study of Cancer that has completed, run by GlaxoSmithKline. The registered enrollment target is 23 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954043, a Phase 1 study of Cancer, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 6
- Study locations
Study Summary
The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate). The study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data collected from this study will be used to inform recommendations regarding use of concomitant medications with dabrafenib and future clinical pharmacologic evaluation of dabrafenib.
Primary Outcome
Blood samples will be collected to assess PK parameters including: maximum observed concentration (Cmax)
Conditions Studied
Interventions
- DRUG Dabrafenib 150 mg twice a day (BID)
- DRUG Rabeprazole 40 mg once daily (OD)
- DRUG Rifampin 600 mg OD
Study Locations (6)
Victoria
- GSK Investigational Site - Heidelberg
- GSK Investigational Site - Melbourne
Arizona
- GSK Investigational Site - Goodyear
Texas
- GSK Investigational Site - Dallas
Washington
- GSK Investigational Site - Tacoma
Other
- GSK Investigational Site - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-12-20 |
| Est. Completion | 2016-02-29 |
| Phase | Phase 1 |
What the finished NCT01954043 record still lists
NCT01954043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which Dabrafenib 150 mg twice a day (BID) is the first listed.
NCT01954043 lists 6 locations in 5 states (Victoria, Arizona, Texas).
Frequently Asked Questions
What is clinical trial NCT01954043 about?
NCT01954043 is a clinical study titled "A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors". The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate). The study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data collected from this study will b...
What is the current status of trial NCT01954043?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2013-12-20. Estimated completion is 2016-02-29.
What conditions does trial NCT01954043 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT01954043?
The interventions under investigation include: Dabrafenib 150 mg twice a day (BID) (DRUG), Rabeprazole 40 mg once daily (OD) (DRUG), Rifampin 600 mg OD (DRUG).
Who is sponsoring clinical trial NCT01954043?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01954043 being conducted?
This trial has 6 study locations across Arizona, Texas, Washington, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01954043's enrollment target sits among peer trials
23 548th of 615 higher than 63 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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