NCT02384850 - Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor In Patients With Metastatic Colorectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

March 9, 2017

Study Completion Date

March 9, 2017

Conditions

Colorectal Neoplasm

Interventions

DRUG

Selinexor

Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level 2: 60 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level 3: 80 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle.

DRUG

Oxaliplatin

85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle

DRUG

5-FU

400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3

DRUG

Folinic Acid

400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle

Trial Locations (2)

1200

University Hospital Antwerpen, Antwerp

20246

University Hospital Hamburg, Hamburg