166
Participants
Start Date
December 19, 2012
Primary Completion Date
June 18, 2020
Study Completion Date
June 18, 2020
Dabrafenib
Each capsule contains 50 mg or 75 mg of GSK2118436; 50 mg strength capsules are Swedish orange (dark red) opaque hypromellose size 2 capsules and 75 mg strength capsules are pink opaque hypromellose size 1 capsules. The initial dosing regimen will be twice daily (BID) continuous oral daily dosing.
Trametinib
Each tablet contains 0.5mg or 2.0 mg GSK1120212; 0.5 mg is yellow modified oval biconvex film-coated tablets of size 4.8 mm X 8.9 mm and 2 mg as pink round biconvex film coated tablets;7.5 mm in diameter. The initial dosing regimen will be once daily continuous oral daily dosing.
Panitumumab
Panitumumab is a sterile, colorless, translucent-to-white amorphous, proteinaceous powder available as 100 mg panitumumab in 5 mL (20 mg/mL) single-use vial; 200 mg panitumumab in 10 mL (20 mg/mL) single-use vial; 400 mg panitumumab in 20 mL (20 mg/mL) single-use vial; to be administered as an intravenous infusion over 60 minutes, every 14 days. Doses higher than 1000 mg should be administered over 90 minutes.
5-fluorouracil
5-fluorouracil-based chemotherapy
Novartis Investigative Site, Brussels
Novartis Investigative Site, Leuven
Novartis Investigative Site, Candiolo
Novartis Investigative Site, New York
Novartis Investigative Site, Philadelphia
Novartis Investigative Site, Milan
Novartis Investigative Site, Chapel Hill
Novartis Investigative Site, Nashville
Novartis Investigative Site, Paris
Novartis Investigative Site, Scottsdale
Novartis Investigative Site, San Francisco
Novartis Investigative Site, Villejuif
Novartis Investigative Site, Boston
Novartis Investigative Site, Boston
Novartis Investigative Site, Aichi
Novartis Investigative Site, Chiba
Novartis Investigative Site, Amsterdam
Novartis Investigative Site, Utrecht
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Birmingham
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY