Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01767623
The ClinicalTrials.gov registry entry for NCT01767623 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (100% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 3 distinct geographic areas - top geographies include 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
Similar trials for Neoplasms
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.
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
RECRUITING · Phase 1
-
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
RECRUITING · Phase 1
-
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
RECRUITING · Phase 1
-
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
RECRUITING · Phase 1
-
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
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.