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NCT01750918 · ClinicalTrials.gov registry record · Phase 1
BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 166
- Enrollment target
NCT01750918: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01750918 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 166 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01750918, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 166 participants
- Enrollment target
Study Summary
This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the combination of a BRAF inhibitor and a MEK inhibitor (trametinib (T); GSK1120212) in patients with BRAF-mutant V600E advanced or mCRC. The goal was to: 1) Determine RP2R/MTD for doublet (D+P) and triplet (D+T+P) combinations in Part 1; 2) Assess clinical activity for these combinations in Part 2; 3) Determine RP2R/MTD for double (T+P) combination in Part 4A, and assess clinical activity of this combination in two patient populations in Part 4B (patients with BRAF-V600E mutation-positive advanced or metastatic CRC and patients with advanced or metastatic CRC with secondary resistance to anti-EGFR therapy).
Primary Outcome
The distribution of adverse events was done via the analysis of frequencies for Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Interventions
- DRUG Trametinib
- DRUG Dabrafenib
- DRUG Panitumumab
- DEVICE 5-fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2012-12-19 |
| Est. Completion | 2020-06-18 |
| Phase | Phase 1 |
What the finished NCT01750918 record still lists
NCT01750918 is an interventional study that assigns participants to a tested intervention. The registered 166 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 (177% higher).
The record links to 0 conditions, and to 4 interventions - of which Trametinib is the first listed.
NCT01750918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01750918 about?
NCT01750918 is a clinical study titled "BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)". This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the combination of a BRAF inhibitor and a MEK inhibitor (trametinib (T); GSK1...
What is the current status of trial NCT01750918?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 166 participants. The study started on 2012-12-19. Estimated completion is 2020-06-18.
What interventions are being tested in trial NCT01750918?
The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG), Panitumumab (DRUG), 5-fluorouracil (DEVICE).
Who is sponsoring clinical trial NCT01750918?
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 NCT01750918's enrollment target sits among peer trials
166 330th of 2000 higher than 1,669 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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