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A Phase I, Dose Escalation Study of BNC101 in Patients With Metastatic Colorectal Cancer.

NCT02726334 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-01-16

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose (which will be the dose recommended for a Phase 2 study), safety, tolerability and pharmacokinetic profile (study of movement of the drug within the body, including absorption and distribution) of the study drug, BNC101 when administered intravenously as a single agent or in combination with chemotherapy in patients with metastatic colorectal cancer who have failed at least 1 or 2 lines of chemotherapy.

Conditions

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.

Sponsors & Collaborators

  • CPR Pharma Services Pty Ltd, Australia

    collaborator INDUSTRY

  • Bionomics Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-12-31
Completion
2018-02-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02726334 on ClinicalTrials.gov