A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

NCT ID: NCT01776307

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2020-04-30

Brief 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.

Detailed Description

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BBI608 in combination with cetuximab

Group Type: EXPERIMENTAL

BBI608

Intervention Type: DRUG

BBI608 is administered at 500 mg po bid continuously.

Cetuximab

Intervention Type: DRUG

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.

BBI608 in combination with panitumumab

Group Type: EXPERIMENTAL

BBI608

Intervention Type: DRUG

BBI608 is administered at 500 mg po bid continuously.

Panitumumab

Intervention Type: DRUG

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

BBI608 in combination with capecitabine

Group Type: EXPERIMENTAL

BBI608

Intervention Type: DRUG

BBI608 is administered at 500 mg po bid continuously.

Capecitabine

Intervention Type: DRUG

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

Interventions

BBI608

BBI608 is administered at 500 mg po bid continuously.

Intervention Type: DRUG

Panitumumab

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Napabucasin; BB608; BBI-608; Vectibix; Xeloda; Erbitux

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William J. Edenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Translational Oncology Research, Greenville Hospital System

Locations

Mayo Clinic

Scottsdale, Arizona, United States

USOR - Rocky Mountain Cancer Center

Denver, Colorado, United States

Mayo Clinic

Jacksonville, Florida, United States

USOR - Minnesota Oncology Hematology

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

USOR - Northwest Cancer Specialists

Portland, Oregon, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Institute for Translational Oncology Research, Greenville Hospital System

Greenville, South Carolina, United States

USOR - Texas Oncology Dallas

Dallas, Texas, United States

US Oncology Research

The Woodlands, Texas, United States

USOR - Texas Oncology Tyler

Tyler, Texas, United States

USOR - Virginia Cancer Specialists

Fairfax, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BBI608-224

Identifier Type: -

Identifier Source: org_study_id