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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: Completed Phase 1 study of Metastatic Melanoma, BRAF V600 Mutation Positive, sponsored by Genentech.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 11 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02608034 record still lists
NCT02608034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
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 lists 11 locations in 2 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02608034's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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