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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Biothera
Sponsor:
Information provided by (Responsible Party):
Biothera
ClinicalTrials.gov Identifier:
NCT01309126
First received: February 8, 2011
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Biological: Imprime PGG + cetuximab
Drug: Cetuximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination With Cetuximab (Erbitux®) in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Biothera:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Rate of complete response (CR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Rate of partial response (PR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Rate of overall response (CR + PR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of the dosing regimen as measured by the incidence and severity of adverse events observed in study participants [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Sparse pharmacokinetic profile of Imprime PGG will be determined to expand current Imprime PGG PK data [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Samples for sparse PK will be taken at specified times on Cycle 1/Day 1 in the first 30 available subjects randomized to Arm 1 (Subjects 1-30). Samples will be collected, at multiple times, in the next 60 subjects randomized to Arm 1 who reach Cycle 2/Day 1 of dosing (subjects 31-90). Additionally, any subject after the first 90 subjects (subjects 91-795) who have a screening/baseline calculated creatinine clearance (based on age, weight and serum creatinine) of <60 mL/minute will have sparse PK samples collected.

  • Change in Quality of Life [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 795
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Imprime PGG + cetuximab
Biological/Vaccine + Drug
Biological: Imprime PGG + cetuximab
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)
Other Names:
  • Imprime PGG
  • Cetuximab (Erbitux)
Active Comparator: Arm 2: cetuximab
Drug
Drug: 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)
Other Name: Cetuximab (Erbitux)

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309126

Contacts
Contact: Nick Niles 908-453-3317 nniles@cmedresearch.com

  Hide Study Locations
Locations
United States, Alabama
Northwest Alabama Cancer Center Recruiting
Florence, Alabama, United States, 35630
Contact: Nick Niles       nniles@cmedresearch.com   
Principal Investigator: Hemant Patel, MD         
United States, Arkansas
Highlands Oncology Group Recruiting
Bentonville, Arkansas, United States, 72703
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: J. Thaddeus Beck, MD         
United States, California
Pacific Medical Center Recruiting
Anaheim, California, United States, 92801
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Veena Charu, MD         
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Ravi Patel, MD         
Providence St. Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Gregg Olsen, MD         
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92903
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Tony Reid, MD, PhD         
Kenmar Research Institute Recruiting
Los Angeles, California, United States, 90057
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Merrill Shum, MD         
United States, Florida
AMPM Research Clinic Recruiting
Miami Gardens, Florida, United States, 33169
Contact: Nick Niles       nniles@cmedresearch.com   
Principal Investigator: Luis Villa Jr., MD         
MD Anderson Cancer Center Recruiting
Orlando, Florida, United States, 32806
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Sajeve Thomas, MD         
United States, Hawaii
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Jared Acoba, MD         
United States, Illinois
Medical and Surgical Specialists Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: John McClean, MD         
Illinois Cancer Specialists Recruiting
Niles, Illinois, United States, 60714
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Leonard Klein, MD         
United States, Indiana
Indiana University Cancer Center Recruiting
Beech Grove, Indiana, United States, 46237
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Nadeem Ikhlaque, MD         
United States, Kentucky
University of Louisville/James Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Vivek Sharma, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Jeffrey Meyerhardt, MD, MPH         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Jeffrey Meyerhardt, MD, MPH         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Ira Wollner, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Anne Blaes, MD         
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri- Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Akm Mosharraf Hossain, MD, MPH         
United States, Nebraska
Oncology Hematology West PC dba Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Ralph Hauke, MD         
United States, New York
Hematology and Oncology Associates of Central NY Recruiting
East Syracuse, New York, United States, 13057
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Benny Wong, MD         
New York Oncology, Hematology, P.C. Recruiting
Hudson, New York, United States, 12534
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Linda DeMarco, MD         
United States, Ohio
Gabrail Cancer Centr Research Recruiting
Canton, Ohio, United States, 44718
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Nashat Gabrail, MD         
Signal Point Hematology/Oncology Recruiting
Middletown, Ohio, United States, 45042
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Nandagopal Vrindavanam, MD         
Toledo Community Oncology Program- Toledo Community Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Rex B Mowat, MD         
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Eugene, Oregon, United States, 97401
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Glenn Buchanan, MD         
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Todd Crocenzi, MD         
United States, South Carolina
Cancer Centers of the Carolinas Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Ki Y Chung, MD         
United States, Tennessee
The Jones Clinic Recruiting
Germantown, Tennessee, United States, 38138
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Michael Jones, MD         
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37915
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Tracy Dobbs, MD         
United States, Texas
Texas Oncology-Amarillo Recruiting
Amarillo, Texas, United States, 79106
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Leonardo Forero, MD         
Texas Oncology - Dallas Presbyterian Hospital Recruiting
Dallas, Texas, United States, 75231
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Kristi McIntyre, MD         
Texas Oncology - Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Andrew McCollum, MD         
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75201
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: John Nemunaitis, MD         
Texas Oncology Denton South Recruiting
Denton, Texas, United States, 76210
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Sharad Jain, MD         
Texas Oncology - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Robert Ruxer, Jr., MD         
Texas Oncology - Lewisville Recruiting
Lewisville, Texas, United States, 75067
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Derrick Nguyen, MD         
Texas Oncology-Seton Williamson Recruiting
Round Rock, Texas, United States, 78665
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Vivian Cline-Burkhardt, MD         
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78217
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Allyson Harroff, MD         
Texas Oncology - Sherman Recruiting
Sherman, Texas, United States, 75090
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Tammy Roque, MD         
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Donald Richards, MD         
United States, Utah
Northern Utah Associates Recruiting
Ogden, Utah, United States, 84403
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Vincent L Hansen, MD         
United States, Virginia
Virginia Oncology Associates Recruiting
Newport News, Virginia, United States, 23606
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: David Chang, MD         
Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care Recruiting
Roanoke, Virginia, United States, 24014
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Mark Kochenderfer, MD         
France
Centre Georges Francois Leclerc Active, not recruiting
Dijon, France, 21000
Centre d' Oncologie de Gentilly Recruiting
Nancy, France, 54000
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Dominique Spaeth, MD         
Germany
Medizinisches Versorgungszentrum Ãrzteforum Seestrabe Recruiting
Berlin, Germany, 13347
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Alexander Schmittel, MD         
Ãrzteforum Henningsdorf Darmzentrum Oberhavel Recruiting
Hennigsdorf, Germany, 16761
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Andrea Speidel, MD         
Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie Recruiting
Kassel, Hessen, Germany, 34125
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Martin Wolf, Prof, MD         
Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin Recruiting
Koeln, Nordrhein Westfalen, Germany, 50937
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Thomas Zander, MD         
Schwerpunktpraxis für Hämatologie und Onkologie Recruiting
Magdeburg, Germany, 39104
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Hendrik Kroening, MD         
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Thomas Ettrich, MD         
Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie Recruiting
Wuppertal, Germany, 42283
Contact: Nick Niles    (908)453-3317    nniles@cmedresearch.com   
Principal Investigator: Andreas Erhardt, MD         
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico, 00927
Contact: Nick Niles    908-453-3317    nniles@cmedresearch.com   
Principal Investigator: Deana Hallman Navarro, MD         
Sponsors and Collaborators
Biothera
  More Information

Additional Information:
No publications provided

Responsible Party: Biothera
ClinicalTrials.gov Identifier: NCT01309126     History of Changes
Other Study ID Numbers: BT-CL-PGG-CRC1031
Study First Received: February 8, 2011
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Ministry of Health

Keywords provided by Biothera:
Colorectal Cancer
KRAS Wild Type
Imprime PGG
Cetuximab
Phase 3
Efficacy
Safety
Recurrent or Progressive KRAS Wild Type Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014