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NCT01336634 · ClinicalTrials.gov registry record · Phase 2
Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 177
- Enrollment target
NCT01336634: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01336634 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 177 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01336634, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 177 participants
- Enrollment target
Study Summary
This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmation testing for the BRAF V600E mutation was performed and a sufficient number of subjects were enrolled with the intent of having at least 125 centrally confirmed subjects among the three cohorts.
Primary Outcome
ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) by investigator assessment as per RECIST v1 .1 criteria. Specifically, ORR = (number of subjects with a confirmed best overall response of CR or PR) divided by the total number of subjects in the corresponding analysis population.
Interventions
- DRUG Trametinib
- DRUG Dabrafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2011-08-05 |
| Est. Completion | 2021-01-07 |
| Phase | Phase 2 |
What the finished NCT01336634 record still lists
NCT01336634 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Trametinib is the first listed.
NCT01336634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01336634 about?
NCT01336634 is a clinical study titled "Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.". This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmati...
What is the current status of trial NCT01336634?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 177 participants. The study started on 2011-08-05. Estimated completion is 2021-01-07.
What interventions are being tested in trial NCT01336634?
The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT01336634?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01336634's enrollment target sits among peer trials
177 394th of 2000 higher than 1,607 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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