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A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

NCT01776307 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-11-15

Study results available
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Summary

This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.

Conditions

Interventions

DRUG

BBI608

BBI608 is administered at 500 mg po bid continuously.

DRUG

Panitumumab

Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.

DRUG

Capecitabine

Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.

DRUG

Cetuximab

Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • William J. Edenfield, MD · Institute for Translational Oncology Research, Greenville Hospital System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2018-06-30
Completion
2020-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01776307 on ClinicalTrials.gov