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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 NilesPh: 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, MDPrincipal Investigator
Arkansas
  Bentonville
 Highlands Oncology Group - Bentonville
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Joseph Thaddeus BeckPrincipal Investigator
California
  Anaheim
 Pacific Cancer Medical Center, Incorporated
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Veena Charu, MDPrincipal Investigator
  Bakersfield
 Comprehensive Blood and Cancer Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Ravindranath PatelPrincipal 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, MDPrincipal Investigator
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Tony Reid, MD, PhDPrincipal Investigator
  Los Angeles
 Kenmar Research Institute
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Merrill Shum, MDPrincipal Investigator
Florida
  Miami Gardens
 AMPM Research Clinic
 Nick Niles
  Email: nniles@cmedresearch.com
 Luis Villa Jr., MDPrincipal Investigator
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Sajeve Thomas, MDPrincipal Investigator
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Jared Acoba, MDPrincipal Investigator
Illinois
  Galesburg
 Medical and Surgical Specialists, LLC
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 John McClean, MDPrincipal Investigator
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Leonard Klein, MDPrincipal Investigator
Indiana
  Beech Grove
 Indiana University Cancer Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Nadeem Ikhlaque, MDPrincipal Investigator
Kentucky
  Louisville
 James Graham Brown Cancer Center at University of Louisville
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Vivek Sharma, MDPrincipal 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, MPHPrincipal Investigator
 Massachusetts General Hospital
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Jeffrey Meyerhardt, MD, MPHPrincipal Investigator
Michigan
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Ira Wollner, MDPrincipal Investigator
Minnesota
  Minneapolis
 Masonic Cancer Center at University of Minnesota
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Anne Blaes, MDPrincipal 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, MPHPrincipal Investigator
Nebraska
  Omaha
 Oncology Hematology West PC dba Nebraska Cancer Specialists
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Ralph Hauke, MDPrincipal Investigator
New York
  East Syracuse
 Hematology and Oncology Associates of Central NY
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Benny Wong, MDPrincipal Investigator
  Hudson
 New York Oncology, Hematology, P.C.
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Linda DeMarco, MDPrincipal Investigator
Ohio
  Canton
 Gabrail Cancer Center - Canton Office
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Nashat Yousif GabrailPrincipal Investigator
  Middletown
 Signal Point Hematology Oncology Incorporated
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Nandagopal Vrindavanam, MDPrincipal Investigator
  Toledo
 CCOP - Toledo Community Hospital
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Rex B Mowat, MDPrincipal Investigator
Oregon
  Eugene
 Willamette Valley Cancer Center - Eugene
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Glenn Buchanan, MDPrincipal Investigator
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Todd S. CrocenziPrincipal Investigator
South Carolina
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Ki Y Chung, MDPrincipal Investigator
Tennessee
  Germantown
 Jones Clinic - Germantown
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 C. Michael JonesPrincipal Investigator
  Knoxville
 Tennessee Cancer Specialists - Tower at Parkwest
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Tracy Dobbs, MDPrincipal Investigator
Texas
  Amarillo
 Texas Oncology, PA - Amarillo
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Leonardo Forero, MDPrincipal Investigator
  Dallas
 Mary Crowley Medical Research Center at Sammons Cancer Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 John J. NemunaitisPrincipal Investigator
 Texas Oncology - Dallas Presbyterian Hospital
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Kristi McIntyre, MDPrincipal Investigator
 Texas Oncology, PA at Charles A. Sammons Cancer Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Andrew McCollum, MDPrincipal Investigator
  Denton
 Texas Oncology Denton South
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Sharad Jain, MDPrincipal Investigator
  Fort Worth
 Texas Oncology - Fort Worth
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Robert Ruxer, Jr., MDPrincipal Investigator
  Lewisville
 Texas Oncology, PA at Lake Vista Cancer Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Derrick Nguyen, MDPrincipal Investigator
  Round Rock
 Texas Oncology-Seton Williamson
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Vivian Cline-Burkhardt, MDPrincipal Investigator
  San Antonio
 Cancer Care Centers of South Texas - Medical Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Allyson Harroff, MDPrincipal Investigator
  Sherman
 Texas Oncology - Sherman
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Tammy Roque, MDPrincipal Investigator
  Tyler
 Tyler Cancer Center
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Donald A. RichardsPrincipal Investigator
Utah
  Ogden
 Utah Hematology Oncology, PC
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Vincent L Hansen, MDPrincipal Investigator
Virginia
  Newport News
 Virginia Oncology Associates - Newport News
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 David Chang, MDPrincipal 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, MDPrincipal Investigator
France
  Nancy
 Centre d' Oncologie de Gentilly
 Nick Niles Ph: (908)453-3317
  Email: nniles@cmedresearch.com
 Dominique Spaeth, MDPrincipal Investigator
Germany
  Berlin
 Medizinisches Versorgungszentrum Ãrzteforum Seestrabe
 Nick Niles Ph: (908)453-3317
  Email: nniles@cmedresearch.com
 Alexander Schmittel, MDPrincipal Investigator
  Hennigsdorf
 Ãrzteforum Henningsdorf Darmzentrum Oberhavel
 Nick Niles Ph: (908)453-3317
  Email: nniles@cmedresearch.com
 Andrea Speidel, MDPrincipal 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, MDPrincipal 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, MDPrincipal Investigator
  Magdeburg
 Schwerpunktpraxis für Hämatologie und Onkologie
 Nick Niles Ph: (908)453-3317
  Email: nniles@cmedresearch.com
 Hendrik Kroening, MDPrincipal Investigator
  Ulm
 Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
 Nick Niles Ph: (908)453-3317
  Email: nniles@cmedresearch.com
 Thomas Ettrich, MDPrincipal 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, MDPrincipal Investigator
Puerto Rico
  San Juan
 Fundacion de Investigacion de Diego
 Nick Niles Ph: 908-453-3317
  Email: nniles@cmedresearch.com
 Deana Hallman Navarro, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01309126
ClinicalTrials.gov processed this data on August 18, 2014

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.

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