BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

December 19, 2012

Primary Completion Date

June 18, 2020

Study Completion Date

June 18, 2020

Conditions
Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DEVICE

5-fluorouracil

5-fluorouracil-based chemotherapy

Trial Locations (20)

1200

Novartis Investigative Site, Brussels

3000

Novartis Investigative Site, Leuven

10060

Novartis Investigative Site, Candiolo

10065

Novartis Investigative Site, New York

19104

Novartis Investigative Site, Philadelphia

20162

Novartis Investigative Site, Milan

27599

Novartis Investigative Site, Chapel Hill

37203

Novartis Investigative Site, Nashville

75571

Novartis Investigative Site, Paris

85259

Novartis Investigative Site, Scottsdale

94115

Novartis Investigative Site, San Francisco

94805

Novartis Investigative Site, Villejuif

02114

Novartis Investigative Site, Boston

02215

Novartis Investigative Site, Boston

464-8681

Novartis Investigative Site, Aichi

277-8577

Novartis Investigative Site, Chiba

1066 CX

Novartis Investigative Site, Amsterdam

3584 CX

Novartis Investigative Site, Utrecht

08035

Novartis Investigative Site, Barcelona

B15 2TH

Novartis Investigative Site, Birmingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY