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

July 11, 2017 updated by: HiberCell, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nancy, France, 54000
        • Centre d' Oncologie de Gentilly
      • Berlin, Germany, 13347
        • Medizinisches Versorgungszentrum Ãrzteforum Seestrabe
      • Hennigsdorf, Germany, 16761
        • Ãrzteforum Henningsdorf Darmzentrum Oberhavel
      • Kassel, Hessen, Germany, 34125
        • Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin
      • Magdeburg, Germany, 39104
        • Schwerpunktpraxis für Hämatologie und Onkologie
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
      • Wuppertal, Germany, 42283
        • Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
    • Alabama
      • Florence, Alabama, United States, 35630
        • Northwest Alabama Cancer Center
    • Arkansas
      • Bentonville, Arkansas, United States, 72703
        • Highlands Oncology Group
    • California
      • Anaheim, California, United States, 92801
        • Pacific Medical Center
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Burbank, California, United States, 91505
        • Providence St. Joseph Medical Center
      • La Jolla, California, United States, 92903
        • UCSD Moores Cancer Center
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
    • Florida
      • Miami Gardens, Florida, United States, 33169
        • AMPM Research Clinic
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical and Surgical Specialists
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Indiana
      • Beech Grove, Indiana, United States, 46237
        • Indiana University Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville/James Brown Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri- Columbia
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
    • New York
      • East Syracuse, New York, United States, 13057
        • Hematology and Oncology Associates of Central NY
      • Hudson, New York, United States, 12534
        • New York Oncology, Hematology, P.C.
    • Ohio
      • Middletown, Ohio, United States, 45042
        • Signal Point Hematology/Oncology
      • Toledo, Ohio, United States, 43623
        • Toledo Community Oncology Program- Toledo Community Hospital
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Cancer Centers of the Carolinas
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic
      • Knoxville, Tennessee, United States, 37915
        • Tennessee Cancer Specialists
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology-Amarillo
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Dallas Presbyterian Hospital
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75201
        • Mary Crowley Cancer Research Center
      • Denton, Texas, United States, 76210
        • Texas Oncology Denton South
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology - Fort Worth
      • Lewisville, Texas, United States, 75067
        • Texas Oncology - Lewisville
      • Round Rock, Texas, United States, 78665
        • Texas Oncology-Seton Williamson
      • San Antonio, Texas, United States, 78217
        • Cancer Care Centers of South Texas
      • Sherman, Texas, United States, 75090
        • Texas Oncology - Sherman
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Imprime PGG + cetuximab
Biological/Vaccine + Drug
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
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:
  • Cetuximab (Erbitux)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 18 months
18 months
Rate of complete response (CR)
Time Frame: 18 months
18 months
Rate of partial response (PR)
Time Frame: 18 months
18 months
Rate of overall response (CR + PR)
Time Frame: 18 months
18 months
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
18 months
Sparse pharmacokinetic profile of Imprime PGG will be determined to expand current Imprime PGG PK data
Time Frame: 18 months
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.
18 months
Change in Quality of Life
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 8, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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