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NCT02608034 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
A Phase 1 study of Metastatic Melanoma, BRAF V600 Mutation Positive, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 11
- Study locations
NCT02608034 is a Phase 1 study of Metastatic Melanoma, BRAF V600 Mutation Positive that has completed, run by Genentech. The registered enrollment target is 32 participants. The trial reports 11 study locations across 2 states.
The verdict
NCT02608034, a Phase 1 study of Metastatic Melanoma, BRAF V600 Mutation Positive, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 11
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-05-26 |
| Est. Completion | 2018-09-10 |
| Phase | Phase 1 |
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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, categorized as Phase 1. 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 332 total studies on file at ClinicalTrials.gov.
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.
NCT02608034 reports 11 study locations spanning 2 distinct geographic areas - top geographies include Other, Texas.
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.
What interventions are being tested in trial NCT02608034?
The interventions under investigation include: Rifampin (DRUG), Vemurafenib (DRUG), Itraconazole (DRUG).
Who is sponsoring clinical trial NCT02608034?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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.
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