BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
Completed · Phase 1/Phase 2
Conditions studied: Cancer
In brief
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).
Key facts
- Study ID
- NCT01750918
- Run by
- Novartis Pharmaceuticals
- People needed
- 166
- Starts
- 2012-12-19
- Expected to finish
- 2020-06-18
- Last updated by the study team
- 2021-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Scottsdale, Arizona, United States
- Novartis Investigative Site — San Francisco, California, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — New York, New York, United States
- Novartis Investigative Site — Chapel Hill, North Carolina, United States
- Novartis Investigative Site — Philadelphia, Pennsylvania, United States
- Novartis Investigative Site — Nashville, Tennessee, United States
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Villejuif, France
- Novartis Investigative Site — Candiolo, Italy
- Novartis Investigative Site — Milan, Italy
- Novartis Investigative Site — Aichi, Japan
- Novartis Investigative Site — Chiba, Japan
- Novartis Investigative Site — Amsterdam, Netherlands
- Novartis Investigative Site — Utrecht, Netherlands
- Novartis Investigative Site — Barcelona, Spain
- Novartis Investigative Site — Birmingham, United Kingdom
Full record on ClinicalTrials.gov
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