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NCT02124772 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 139
- Enrollment target
NCT02124772: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02124772 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 139 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124772, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 139 participants
- Enrollment target
Study Summary
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors. Part A was a repeat dose, dose escalation and expansion phase that identified the recommended phase II dose (RP2D) of trametinib monotherapy. Part B evaluated the preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects. Part C was aimed to determine the safety, tolerability and preliminary activity of the RP2D of trametinib in combination with a limited dose escalation of dabrafenib. Part D evaluated the preliminary activity of trametinib in combination with dabrafenib in 2 disease-specific cohorts of subjects. The overall goal of this trial was to efficiently establish safe, pharmacologically relevant dose of trametinib monotherapy and trametinib in combination with dabrafenib in infants, children and adolescents and determine preliminary activity of trametinib monotherapy and trametinib in combination with dabrafenib in selected recurrent, refractory or unresectable childhood tumors.
Primary Outcome
Incidence of treatment emergent adverse events is defined as number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. The number of participants in each category is reported in the table.
Interventions
- DRUG Trametinib
- DRUG Dabrafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2015-01-15 |
| Est. Completion | 2020-12-29 |
| Phase | Phase 1 |
What the finished NCT02124772 record still lists
NCT02124772 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 2 interventions - of which Trametinib is the first listed.
NCT02124772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124772 about?
NCT02124772 is a clinical study titled "Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations". This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors. Part A was a repeat dose, dose escalation and expansion phase that identified the recommended phase II dose (RP2D) of trametinib monotherapy...
What is the current status of trial NCT02124772?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 2015-01-15. Estimated completion is 2020-12-29.
What interventions are being tested in trial NCT02124772?
The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT02124772?
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 NCT02124772's enrollment target sits among peer trials
139 418th of 2000 higher than 1,583 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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