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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.

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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

FieldValue
Enrollment Target 27 participants
Start Date 2013-07
Est. Completion 2015-11
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.