NCT02726334 - A Phase I, Dose Escalation Study of BNC101 in Patients With Metastatic Colorectal Cancer. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

February 28, 2018

Conditions

Colorectal Cancer

Interventions

DRUG

BNC101 Solution for Infusion

Administration: Administered via IV infusion once a week over 60 minutes (1 hour).

DRUG

BNC101 in combination with FOLFIRI

"BNC101 - Starting dose as determined by Arm A portion (one dose level below recommended Phase 2 dose).~BNC101 Administration: Administered via IV Infusion once a week over 60 minutes (1 hour).~FOLFIRI components:~Irinotecan (IRI) - Starting dose 180 mg/m2 (over 90 minutes on Day 1) Leucovorin (LV) - Starting dose 400 mg/m2 (administered over 120 minutes on Day 1 concurrently with IRI) 5-FU bolus - Starting dose 400 mg/m2 (administered after LV on Day 1, then) 5-FU infusion - Starting dose 2400 mg/m2 (administered over 48 hours starting on Day 1)~FOLFIRI Cycles are repeated every 14 days."

Trial Locations (4)

3050

Royal Melbourne Hospital, Melbourne

3084

Austin Health, Heidelberg

3168

Monash Health, Clayton

5042

Flinders Medical Centre, Bedford Park