Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

NCT02608034 · View on ClinicalTrials.gov ↗

Study Summary

This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF where the participant has no acceptable standard treatment options.

Interventions

  • DRUG Rifampin
  • DRUG Vemurafenib
  • DRUG Itraconazole

Study Locations (11)

Other

  • Rambam Health Care Campus; Oncology — Haifa
  • Hadassah Ein Karem Hospital; Oncology Dept — Jerusalem
  • Tel Aviv Sourasky Medical Center; Pharmacy — Tel Aviv
  • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan — Kazan'
  • FSBSI "N. N. Blokhin Russian Cancer Research Center" — Moscow
  • St. Petersburg Oncology Hospital — Saint Petersburg
  • Seoul National University Hospital — Seoul
  • Samsung Medical Center; Gastroenterology — Seoul
  • Asan Medical Center; Division of Oncology — Seoul
  • Severance Hospital - Yonsei Uni ; Obstetrics & Gynaecology Dept. — Seoul

Texas

  • Mary Crowley Medical Research Center — Dallas

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2016-05-26
Est. Completion 2018-09-10
Phase Phase 1

Sponsor

Genentech

206 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02608034

The ClinicalTrials.gov registry entry for NCT02608034 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Melanoma, BRAF V600 Mutation Positive appearing as the primary indexed condition, and to 3 interventions — of which Rifampin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02608034 reports 11 study locations spanning 2 distinct geographic areas — top geographies include Other, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02608034 about?

NCT02608034 is a clinical study titled "A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State". This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable Stage IIIC or Stage IV metastat...

What is the current status of trial NCT02608034?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-05-26. Estimated completion is 2018-09-10.

What conditions does trial NCT02608034 study?

This clinical trial studies the following conditions: Metastatic Melanoma, BRAF V600 Mutation Positive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02608034?

The interventions under investigation include: Rifampin (DRUG), Vemurafenib (DRUG), Itraconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02608034?

This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02608034 being conducted?

This trial has 11 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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