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NCT01677741 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
A Phase 1 study of Neoplasms, Brain, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT01677741: Completed Phase 1 study of Neoplasms, Brain, sponsored by Novartis Pharmaceuticals.
NCT01677741 is a Phase 1 study of Neoplasms, Brain that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677741, a Phase 1 study of Neoplasms, Brain, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients participated in only either part 1 or part 2 of the study.
Primary Outcome
The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Conditions Studied
Interventions
- DRUG Dabrafenib
Study Locations (20)
Other
- Novartis Investigative Site - Copenhagen
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Toulouse
- Novartis Investigative Site - Villejuif
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Jerusalem
Arizona
- Novartis Investigative Site - Phoenix
California
- Novartis Investigative Site - Orange
Maryland
- Novartis Investigative Site - Baltimore
Massachusetts
- Novartis Investigative Site - Boston
New York
- Novartis Investigative Site - New York
Ohio
- Novartis Investigative Site - Cincinnati
Tennessee
- Novartis Investigative Site - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2013-05-23 |
| Est. Completion | 2020-12-04 |
| Phase | Phase 1 |
What the finished NCT01677741 record still lists
NCT01677741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 1 condition, with Neoplasms, Brain appearing as the primary indexed condition, and to 1 intervention - of which Dabrafenib is the first listed.
NCT01677741 names 20 study sites across 13 states, led by Other, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT01677741 about?
NCT01677741 is a clinical study titled "A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects". This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2...
What is the current status of trial NCT01677741?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2013-05-23. Estimated completion is 2020-12-04.
What conditions does trial NCT01677741 study?
This clinical trial studies the following conditions: Neoplasms, Brain.
What interventions are being tested in trial NCT01677741?
The interventions under investigation include: Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT01677741?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01677741 being conducted?
This trial has 20 study locations across Arizona, California, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01677741's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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