Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

NCT01309126 | Terminated Phase 3 DMC

• 1 other identifier: BT-CL-PGG-CRC1031
• Study Type: interventional
• Target: 217
• Locations: 4 countries
• Sites: 53

Brief Summary

Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; KRAS Wild Type; Imprime PGG; Cetuximab; Phase 3; Efficacy; Safety; Recurrent or Progressive KRAS Wild Type Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  18 months

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  18 months

• Rate of complete response (CR)

  18 months

• Rate of partial response (PR)

  18 months

• Rate of overall response (CR + PR)

  18 months

• Safety and tolerability of the dosing regimen as measured by the incidence and severity of adverse events observed in study participants

  18 months

Study Arms (2)

Arm 1: Imprime PGG + cetuximab

EXPERIMENTAL

Biological/Vaccine + Drug

Biological: Imprime PGG + cetuximab

Arm 2: cetuximab

ACTIVE COMPARATOR

Drug

Drug: Cetuximab

Interventions

Imprime PGG + cetuximab BIOLOGICAL

Imprime PGG: 4 mg/kg and will be administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36) preceding the administration of cetuximab Cetuximab: initial dose will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2, administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36)

Also known as: Imprime PGG, Cetuximab (Erbitux)

Arm 1: Imprime PGG + cetuximab

Cetuximab DRUG

Cetuximab: initial dose will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2, administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36)

Also known as: Cetuximab (Erbitux)

Arm 2: cetuximab

Eligibility Criteria

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

You may qualify if:

• Is \>18 years old;
• Has recurrent or metastatic carcinoma of the colon or rectum with documented histological or cytological confirmation;
• Must be KRAS WT;
• Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1;
• Has never received cetuximab or panitumumab, and has not received any treatment for colorectal cancer within 30 days prior to the first dose of study treatment under this protocol;
• Has an Eastern Cooperative Oncology Group (ECOG) score of 0-1, with a life expectancy of \>3 months;
• Has received at least 2 prior chemotherapeutic regimens for colorectal cancer;
• Has adequate bone marrow reserve as evidenced by:
• Absolute neutrophil count ≥1,500/μL
• Platelets ≥100,000/μL;
• Has adequate renal function as evidenced by serum creatinine ≤2.5 × the upper limit of normal (ULN) for the reference lab;
• Has adequate hepatic function as evidenced by:
• Aspartate aminotransferase ≤3 × ULN for the reference lab (≤5 × ULN for subjects with known hepatic metastases)
• Alanine aminotransferase ≤3 × ULN for the reference lab (≤5 × ULN for subjects with known hepatic metastases)
• Bilirubin \<1.5 mg/dL or direct bilirubin \<1.0 mg/dL

You may not qualify if:

• Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;
• Has a known hypersensitivity to baker's yeast or has an active yeast infection;
• Has had previous exposure to Betafectin® or Imprime PGG;
• Has an active, uncontrolled infection;
• Has known untreated or symptomatic brain metastases;
• Had a second malignancy within the previous 5 years, except for basal cell carcinoma, cervical intra-epithelial neoplasia or treated prostate cancer with a prostate-specific antigen (PSA) of \<2.0 ng/mL;
• Has known human immunodeficiency virus or acquired immune deficiency syndrome, hepatitis B, hepatitis C, connective tissue disease, or other clinical diagnosis, ongoing or intercurrent illness that in the Investigators opinion should preclude the subject from participation;
• If female, is pregnant or breast-feeding;
• Is receiving concurrent standard and/or investigational anti-cancer therapy or has received such therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication); or
• Has previously received an organ or progenitor/stem cell transplant.

Sponsors & Collaborators

• HiberCell, Inc.: lead

Study Sites (53)

Northwest Alabama Cancer Center

Florence, Alabama, 35630, United States

Location

Highlands Oncology Group

Bentonville, Arkansas, 72703, United States

Location

Pacific Medical Center

Anaheim, California, 92801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Providence St. Joseph Medical Center

Burbank, California, 91505, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92903, United States

Location

Kenmar Research Institute

Los Angeles, California, 90057, United States

Location

AMPM Research Clinic

Miami Gardens, Florida, 33169, United States

Location

MD Anderson Cancer Center

Orlando, Florida, 32806, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Medical and Surgical Specialists

Galesburg, Illinois, 61401, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Indiana University Cancer Center

Beech Grove, Indiana, 46237, United States

Location

University of Louisville/James Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Ellis Fischel Cancer Center at University of Missouri- Columbia

Columbia, Missouri, 65203, United States

Location

Oncology Hematology West PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Hematology and Oncology Associates of Central NY

East Syracuse, New York, 13057, United States

Location

New York Oncology, Hematology, P.C.

Hudson, New York, 12534, United States

Location

Signal Point Hematology/Oncology

Middletown, Ohio, 45042, United States

Location

Toledo Community Oncology Program- Toledo Community Hospital

Toledo, Ohio, 43623, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Cancer Centers of the Carolinas

Spartanburg, South Carolina, 29307, United States

Location

The Jones Clinic

Germantown, Tennessee, 38138, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37915, United States

Location

Texas Oncology-Amarillo

Amarillo, Texas, 79106, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75201, United States

Location

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology Denton South

Denton, Texas, 76210, United States

Location

Texas Oncology - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Texas Oncology - Lewisville

Lewisville, Texas, 75067, United States

Location

Texas Oncology-Seton Williamson

Round Rock, Texas, 78665, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

Location

Centre d' Oncologie de Gentilly

Nancy, 54000, France

Location

Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie

Kassel, Hessen, Germany, 34125, Germany

Location

Medizinisches Versorgungszentrum Ãrzteforum Seestrabe

Berlin, 13347, Germany

Location

Ãrzteforum Henningsdorf Darmzentrum Oberhavel

Hennigsdorf, 16761, Germany

Location

Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin

Koeln, Nordrhein Westfalen, 50937, Germany

Location

Schwerpunktpraxis für Hämatologie und Onkologie

Magdeburg, 39104, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie

Wuppertal, 42283, Germany

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence

Interventions

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: March 4, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

FR (1); DE (7); PR (1); US (44)