Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

Protocol: OSU-13159

Full Title

A Phase II Clinical Study of BBI608 in Adult Patients with Advanced Colorectal Cancer

Purpose

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.

Study Objective

This is an open label, multi-center, Phase 2 study of BBI608 administered in combination

with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and

continuous oral administration of BBI608 for four weeks in combination with either

cetuximab, or panitumumab, or capecitabine.

Are you eligible?

Inclusion Criteria:

Signed written informed consent must be obtained and documented according to

International Conference on Harmonization (ICH), Good Clinical Practice(GCP), the

local regulatory requirements, and permission to use private health information in

accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior

to study-specific screening procedures.

A histologically or cytologically confirmed colorectal cancer that is metastatic,

unresectable, or recurrent.

Patients must have received at least 2 regimens containing

5-Fluorouracil,oxaliplatin, or irinotecan.

Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have

colorectal cancer which is K-Ras wild-type.

≥ 18 years of age.

Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST

1.1).

Karnofsky performance Status ≥ 70%

Male or female patients of child-producing potential must agree to use contraception

or avoidance of pregnancy measures during the study and for 30 days after the last

BBI608 dose.

Females of childbearing potential must have a negative serum pregnancy test.

Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 × upper limit of

normal(ULN), or ≤ 2.5 × ULN with metastatic liver disease.

Hemoglobin (Hgb) ≥ 10 g/dl.

Total bilirubin ≤ 1.5 × ULN.

Creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with

creatinine levels above institutional normal.

Absolute neutrophil count ≥ 1.5 x 10^9/L.

Platelets ≥ 100 x 10^9/L.

Life expectancy ≥ 3 months.

Exclusion Criteria:

Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents

within four weeks of first dose with the exception for a single dose radiation up to

8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days

before beginning the administration of BBI608.

Surgery within 4 weeks prior to first dose.

Any known symptomatic brain metastases requiring steroids. Patients with treated

brain metastases must be stable for 4 weeks after completion of that treatment, with

image documentation required. Patients must have no clinical symptoms from brain

metastases and must be either off steroids or on a stable dose of steroids for at

least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal

metastases are excluded, even if treated.

Pregnant or breastfeeding

Significant gastrointestinal disorder(s), in the opinion of the Principal

Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small

intestine resection)

Unable or unwilling to swallow BBI608 capsules daily.

Uncontrolled intercurrent illness including, but not limited to ongoing or active

infection, clinically significant non-healing or healing wounds, symptomatic

congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant

pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled

infection or psychiatric illness/social situations that would limit compliance with

study requirements.

Colon Cancer Rectal Cancer Gastrointestinal Cancers