NCT02124772 - Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations | Biotech Hunter

Enrollment

139

Participants

Timeline

Start Date

January 15, 2015

Primary Completion Date

December 29, 2020

Study Completion Date

December 29, 2020

Conditions

Cancer

Interventions

DRUG

Trametinib

Trametinib was administered orally, once daily. It was available in tablets (0.125 mg, 0.5 mg, 2 mg dose) as well as in powder form for oral solution (0.05 mg/mL dose).

DRUG

Dabrafenib

Dabrafenib was administered orally, twice daily. The daily dose was divided into two equal doses. It was available in capsules (50 mg and 75 mg), dispersible tablets (10 mg) and powder for oral suspension (10 mg/mL dose).

Trial Locations (16)

2145

Novartis Investigative Site, Westmead

10065

Novartis Investigative Site, New York

19104

Novartis Investigative Site, Philadelphia

20010

Novartis Investigative Site, Washington D.C.

21287

Novartis Investigative Site, Baltimore

45229

Novartis Investigative Site, Cincinnati

55455

Novartis Investigative Site, Minneapolis

75248

Novartis Investigative Site, Paris

94805

Novartis Investigative Site, Villejuif

85016-7710

Novartis Investigative Site, Phoenix

Unknown

Novartis Investigative Site, San Francisco

02115

Novartis Investigative Site, Boston

38105-3678

Novartis Investigative Site, Memphis

M5G 1X8

Novartis Investigative Site, Toronto

SM2 5PT

Novartis Investigative Site, Sutton

WC1N 3JH

Novartis Investigative Site, London