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NCT01765543 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01765543 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 27 participants.
The verdict
NCT01765543, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This open-label, multi-center, three-period, one-sequence study will investigate the effect of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study GO28399 (NCT01739764).
Interventions
- DRUG Rifampin
- DRUG Vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01765543
The ClinicalTrials.gov registry entry for NCT01765543 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rifampin is the first listed.
NCT01765543 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01765543 about?
NCT01765543 is a clinical study titled "A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)". This open-label, multi-center, three-period, one-sequence study will investigate the effect of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acce...
What is the current status of trial NCT01765543?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2013-07. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01765543?
The interventions under investigation include: Rifampin (DRUG), Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01765543?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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