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NCT03340506 · ClinicalTrials.gov registry record · Phase 4
Dabrafenib and/or Trametinib Rollover Study
A Phase 4 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT03340506: Recruiting Phase 4 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Novartis Pharmaceuticals.
NCT03340506 is a Phase 4 study of Non-Small Cell Lung Cancer and Melanoma that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 100 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03340506, a Phase 4 study of Non-Small Cell Lung Cancer and Melanoma, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
Primary Outcome
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
Conditions Studied
Interventions
- DRUG dabrafenib
- DRUG trametinib
Study Locations (20)
Other
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Copenhagen
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Nantes
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Villejuif
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Hamburg
- Novartis Investigative Site - Heidelberg
- Novartis Investigative Site - Budapest
Arizona
- Honor Health Research Institute - Scottsdale
- Honor Health Research Institute - Scottsdale
Maryland
- National Institute Of Health - Bethesda
Ohio
- James Cancer Hospital and Solove Research Institute Ohio State - Columbus
Texas
- Mary Crowley Cancer Research - Dallas
Buenos Aires
- Novartis Investigative Site - Caba
Tyrol
- Novartis Investigative Site - Innsbruck
Baden-Wurttemberg
- Novartis Investigative Site - Mannheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-12-28 |
| Est. Completion | 2030-12-28 |
| Phase | Phase 4 |
What NCT03340506 shows while recruiting
NCT03340506 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).
The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which dabrafenib is the first listed.
NCT03340506 names 20 study sites across 10 states, led by Other, Arizona, Maryland.
Frequently Asked Questions
What is clinical trial NCT03340506 about?
NCT03340506 is a clinical study titled "Dabrafenib and/or Trametinib Rollover Study". This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by ...
What is the current status of trial NCT03340506?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2017-12-28. Estimated completion is 2030-12-28.
What conditions does trial NCT03340506 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Solid Tumor, High Grade Glioma, Rare Cancers.
What interventions are being tested in trial NCT03340506?
The interventions under investigation include: dabrafenib (DRUG), trametinib (DRUG).
Who is sponsoring clinical trial NCT03340506?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03340506 being conducted?
This trial has 20 study locations across Arizona, Maryland, Ohio, Texas, Buenos Aires. 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 NCT03340506's enrollment target sits among peer trials
100 233rd of 454 higher than 212 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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