A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

NCT01776307 | Completed Phase 2 Results

• 1 other identifier: BBI608-224
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 13

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.

Conditions

Colorectal Cancer

Keywords

BBI608

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate

  Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine

  From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months

Secondary Outcomes (14)

• Progression Free Survival

  The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months

• Overall Survival

  4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months.

• Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle

  Blood samples drawn on day 5 during the first study cycle

• Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle

  Blood samples drawn on day 21 during the first study cycle

• Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle

  Blood samples drawn on day 21 during the first study cycle

Study Arms (3)

BBI608 in combination with cetuximab

EXPERIMENTAL

Drug: BBI608; Drug: Cetuximab

BBI608 in combination with panitumumab

EXPERIMENTAL

Drug: BBI608; Drug: Panitumumab

BBI608 in combination with capecitabine

EXPERIMENTAL

Drug: BBI608; Drug: Capecitabine

Interventions

BBI608 DRUG

BBI608 is administered at 500 mg po bid continuously.

Also known as: Napabucasin, BB608, BBI-608

BBI608 in combination with capecitabine; BBI608 in combination with cetuximab; BBI608 in combination with panitumumab

Panitumumab DRUG

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

Also known as: Vectibix

BBI608 in combination with panitumumab

Capecitabine DRUG

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

Also known as: Xeloda

BBI608 in combination with capecitabine

Cetuximab 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.

Also known as: Erbitux

BBI608 in combination with cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (13)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

USOR - Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

USOR - Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

USOR - Northwest Cancer Specialists

Portland, Oregon, 97227, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Institute for Translational Oncology Research, Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

USOR - Texas Oncology Dallas

Dallas, Texas, 75246, United States

Location

US Oncology Research

The Woodlands, Texas, 77380, United States

Location

USOR - Texas Oncology Tyler

Tyler, Texas, 75702, United States

Location

USOR - Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

napabucasin; Panitumumab; Capecitabine; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Tegan Nguyen
• Organization: Sumitomo Dainippon Pharma Oncology

tnguyen@bostonbiomedical.com

617-674-8745

Study Officials

• William J. Edenfield, MD

  Institute for Translational Oncology Research, Greenville Hospital System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 28, 2013
• Study Start: March 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: April 1, 2020
• Last Updated: November 15, 2023
• Results First Posted: June 18, 2021

Record last verified: 2023-11

Locations

US (13)