Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 166 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01750918
The ClinicalTrials.gov registry entry for NCT01750918 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Trametinib is the first listed.
NCT01750918 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.