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NCT01767623 · ClinicalTrials.gov registry record · Phase 1
A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
A Phase 1 study of Neoplasms, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 8
- Study locations
NCT01767623: Completed Phase 1 study of Neoplasms, sponsored by Hoffmann-La Roche.
NCT01767623 is a Phase 1 study of Neoplasms that has completed, run by Hoffmann-La Roche. The registered enrollment target is 8 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (100% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01767623, a Phase 1 study of Neoplasms, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 8
- Study locations
Study Summary
This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function) or 720 mg (severe hepatic impairment) orally twice daily (BID) on Days 1 to 20 (morning dose) and from Day 27 onward until disease progression or unacceptable toxicity occurs.
Conditions Studied
Interventions
- DRUG Vemurafenib
Study Locations (8)
Other
- District General Hospital of Athens Laiko; 1st Internal Medicine Clinic - Athens
- Rambam Health Care Campus - Haifa
- Tel Aviv Sourasky Medical Center - Tel Aviv
- SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2 - Krasnodar
- Ege University Medicine Develoment and Pharmacokinetics Research Center; Pulmonary Diseases - Izmir
- Velindre Cancer Centre - Cardiff
California
- California Cancer Associates for Research & Excellence, Inc. - Encinitas
Victoria
- Peninsula and South Eastern Haematology and Oncology Grou - Frankston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-08-20 |
| Est. Completion | 2017-04-20 |
| Phase | Phase 1 |
What the finished NCT01767623 record still lists
NCT01767623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Vemurafenib is the first listed.
NCT01767623 lists 8 locations in 3 states (Other, California, Victoria).
Frequently Asked Questions
What is clinical trial NCT01767623 about?
NCT01767623 is a clinical study titled "A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants". This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function) or 720 mg (severe hepati...
What is the current status of trial NCT01767623?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-08-20. Estimated completion is 2017-04-20.
What conditions does trial NCT01767623 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT01767623?
The interventions under investigation include: Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01767623?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01767623 being conducted?
This trial has 8 study locations across California, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01767623's enrollment target sits among peer trials
8 157th of 158 higher than 2 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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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