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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryBT-CL-PGG-CRC1031
NCT01309126

Trial Description

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.

Further Study Information

Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS WT colorectal cancer will be randomized in a 2:1 ratio to either:

Arm 1: Imprime PGG and cetuximab or Arm 2: Cetuximab

Approximately 795 subjects will be randomized into the study. Dosing will occur in 6-week cycles. Imprime PGG will be dosed at 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 (Arm 1 only). The initial cetuximab dose (both arms) 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).

Subjects will be dosed until progressive disease (PD) per RECIST 1.1 or discontinuation of study drug for other reasons; e.g., safety. Following completion of the treatment period of the study, subjects will be monitored for survival until death or loss to follow-up. Tumor measurements and determination of tumor responses will be evaluated according to RECIST 1.1. Safety, PK, quality of life, and biomarker parameters will also be assessed.

Eligibility Criteria

Inclusion Criteria:

1. Is >18 years old;

2. Has recurrent or metastatic carcinoma of the colon or rectum with documented histological or cytological confirmation;

3. Must be KRAS WT;

4. Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1;

5. 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;

6. Has an Eastern Cooperative Oncology Group (ECOG) score of 0-1, with a life expectancy of >3 months;

7. Has received at least 2 prior chemotherapeutic regimens for colorectal cancer;

8. Has adequate bone marrow reserve as evidenced by:

  • Absolute neutrophil count ≥1,500/μL
  • Platelets ≥100,000/μL;

9. Has adequate renal function as evidenced by serum creatinine ≤2.5 × the upper limit of normal (ULN) for the reference lab;

10. 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
  • Serum Albumin >3.0 gm/dL

11. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC); and

12. If the subject is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 60 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method).

Exclusion Criteria:

1. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;

2. Has a known hypersensitivity to baker's yeast or has an active yeast infection;

3. Has had previous exposure to Betafectin® or Imprime PGG;

4. Has an active, uncontrolled infection;

5. Has known untreated or symptomatic brain metastases;

6. 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;

7. 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;

8. If female, is pregnant or breast-feeding;

9. 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

10. Has previously received an organ or progenitor/stem cell transplant.

Trial Contact Information

Trial Lead Organizations/Sponsors

Biothera

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Trial Sites

    U.S.A.

    Alabama
    Florence

    Northwest Alabama Cancer Center

    Nick Niles
    Email: nniles@cmedresearch.com

    Hemant Patel, MD
    Principal Investigator

    Arkansas
    Bentonville

    Highlands Oncology Group - Bentonville

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Joseph Thaddeus Beck
    Principal Investigator

    California
    Anaheim

    Pacific Cancer Medical Center, Incorporated

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Veena Charu, MD
    Principal Investigator

    Bakersfield

    Comprehensive Blood and Cancer Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Ravindranath Patel
    Principal Investigator

    Burbank

    Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Gregg Olsen, MD
    Principal Investigator

    La Jolla

    Rebecca and John Moores UCSD Cancer Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Tony Reid, MD, PhD
    Principal Investigator

    Los Angeles

    Kenmar Research Institute

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Merrill Shum, MD
    Principal Investigator

    Florida
    Miami Gardens

    AMPM Research Clinic

    Nick Niles
    Email: nniles@cmedresearch.com

    Luis Villa Jr., MD
    Principal Investigator

    Orlando

    M.D. Anderson Cancer Center at Orlando

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Sajeve Thomas, MD
    Principal Investigator

    Hawaii
    Honolulu

    Cancer Research Center of Hawaii

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Jared Acoba, MD
    Principal Investigator

    Illinois
    Galesburg

    Medical and Surgical Specialists, LLC

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    John McClean, MD
    Principal Investigator

    Niles

    Cancer Care and Hematology Specialists of Chicagoland - Niles

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Leonard Klein, MD
    Principal Investigator

    Indiana
    Beech Grove

    Indiana University Cancer Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Nadeem Ikhlaque, MD
    Principal Investigator

    Kentucky
    Louisville

    James Graham Brown Cancer Center at University of Louisville

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Vivek Sharma, MD
    Principal Investigator

    Massachusetts
    Boston

    Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Jeffrey Meyerhardt, MD, MPH
    Principal Investigator

    Massachusetts General Hospital

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Jeffrey Meyerhardt, MD, MPH
    Principal Investigator

    Michigan
    Detroit

    Josephine Ford Cancer Center at Henry Ford Hospital

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Ira Wollner, MD
    Principal Investigator

    Minnesota
    Minneapolis

    Masonic Cancer Center at University of Minnesota

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Anne Blaes, MD
    Principal Investigator

    Missouri
    Columbia

    Ellis Fischel Cancer Center at University of Missouri- Columbia

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Akm Mosharraf Hossain, MD, MPH
    Principal Investigator

    Nebraska
    Omaha

    Oncology Hematology West PC dba Nebraska Cancer Specialists

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Ralph Hauke, MD
    Principal Investigator

    New York
    East Syracuse

    Hematology and Oncology Associates of Central NY

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Benny Wong, MD
    Principal Investigator

    Hudson

    New York Oncology, Hematology, P.C.

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Linda DeMarco, MD
    Principal Investigator

    Ohio
    Middletown

    Signal Point Hematology Oncology Incorporated

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Nandagopal Vrindavanam, MD
    Principal Investigator

    Toledo

    CCOP - Toledo Community Hospital

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Rex B Mowat, MD
    Principal Investigator

    Oregon
    Eugene

    Willamette Valley Cancer Center - Eugene

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Glenn Buchanan, MD
    Principal Investigator

    Portland

    Providence Cancer Center at Providence Portland Medical Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Todd S. Crocenzi
    Principal Investigator

    South Carolina
    Spartanburg

    Cancer Centers of the Carolinas - Spartanburg

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Ki Y Chung, MD
    Principal Investigator

    Tennessee
    Germantown

    Jones Clinic - Germantown

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    C. Michael Jones
    Principal Investigator

    Knoxville

    Tennessee Cancer Specialists - Tower at Parkwest

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Tracy Dobbs, MD
    Principal Investigator

    Texas
    Amarillo

    Texas Oncology, PA - Amarillo

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Leonardo Forero, MD
    Principal Investigator

    Dallas

    Mary Crowley Medical Research Center at Sammons Cancer Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    John J. Nemunaitis
    Principal Investigator

    Texas Oncology - Dallas Presbyterian Hospital

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Kristi McIntyre, MD
    Principal Investigator

    Texas Oncology, PA at Charles A. Sammons Cancer Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Andrew McCollum, MD
    Principal Investigator

    Denton

    Texas Oncology Denton South

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Sharad Jain, MD
    Principal Investigator

    Fort Worth

    Texas Oncology, PA - Fort Worth

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Robert Ruxer, Jr., MD
    Principal Investigator

    Lewisville

    Texas Oncology, PA at Lake Vista Cancer Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Derrick Nguyen, MD
    Principal Investigator

    Round Rock

    Texas Oncology-Seton Williamson

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Vivian Cline-Burkhardt, MD
    Principal Investigator

    San Antonio

    Cancer Care Centers of South Texas - Medical Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Allyson Harroff, MD
    Principal Investigator

    Sherman

    Texas Oncology - Sherman

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Tammy Roque, MD
    Principal Investigator

    Tyler

    Tyler Cancer Center

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Donald A. Richards
    Principal Investigator

    Utah
    Ogden

    Utah Hematology Oncology, PC

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Vincent L Hansen, MD
    Principal Investigator

    Virginia
    Newport News

    Virginia Oncology Associates - Newport News

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    David Chang, MD
    Principal Investigator

    Roanoke

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

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Mark Kochenderfer, MD
    Principal Investigator

    France

    Nancy

    Centre d' Oncologie de Gentilly

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Dominique Spaeth, MD
    Principal Investigator

    Germany

    Berlin

    Medizinisches Versorgungszentrum Ãrzteforum Seestrabe

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Alexander Schmittel, MD
    Principal Investigator

    Hennigsdorf

    Ãrzteforum Henningsdorf Darmzentrum Oberhavel

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Andrea Speidel, MD
    Principal Investigator

    Kassel, Hessen

    Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Martin Wolf, Prof, MD
    Principal Investigator

    Koeln, Nordrhein Westfalen

    Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Thomas Zander, MD
    Principal Investigator

    Magdeburg

    Schwerpunktpraxis für Hämatologie und Onkologie

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Hendrik Kroening, MD
    Principal Investigator

    Ulm

    Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Thomas Ettrich, MD
    Principal Investigator

    Wuppertal

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

    Nick Niles
    Ph: (908)453-3317
    Email: nniles@cmedresearch.com

    Andreas Erhardt, MD
    Principal Investigator

    Puerto Rico

    San Juan

    Fundacion de Investigacion de Diego

    Nick Niles
    Ph: 908-453-3317
    Email: nniles@cmedresearch.com

    Deana Hallman Navarro, MD
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01309126
    ClinicalTrials.gov processed this data on February 05, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.