Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
NCT ID: NCT01309126
Last Updated: 2017-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
217 participants
INTERVENTIONAL
2011-04-30
2017-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer
NCT00912327
Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
NCT00545545
Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).
NCT02296203
Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
NCT00063141
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
NCT00362102
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: Imprime PGG + cetuximab
Biological/Vaccine + Drug
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)
Arm 2: cetuximab
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HiberCell, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwest Alabama Cancer Center
Florence, Alabama, United States
Highlands Oncology Group
Bentonville, Arkansas, United States
Pacific Medical Center
Anaheim, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Providence St. Joseph Medical Center
Burbank, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Kenmar Research Institute
Los Angeles, California, United States
AMPM Research Clinic
Miami Gardens, Florida, United States
MD Anderson Cancer Center
Orlando, Florida, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Medical and Surgical Specialists
Galesburg, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Indiana University Cancer Center
Beech Grove, Indiana, United States
University of Louisville/James Brown Cancer Center
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri- Columbia
Columbia, Missouri, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Hematology and Oncology Associates of Central NY
East Syracuse, New York, United States
New York Oncology, Hematology, P.C.
Hudson, New York, United States
Signal Point Hematology/Oncology
Middletown, Ohio, United States
Toledo Community Oncology Program- Toledo Community Hospital
Toledo, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Cancer Centers of the Carolinas
Spartanburg, South Carolina, United States
The Jones Clinic
Germantown, Tennessee, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Texas Oncology-Amarillo
Amarillo, Texas, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology Denton South
Denton, Texas, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, United States
Texas Oncology - Lewisville
Lewisville, Texas, United States
Texas Oncology-Seton Williamson
Round Rock, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Texas Oncology - Sherman
Sherman, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care
Roanoke, Virginia, United States
Centre d' Oncologie de Gentilly
Nancy, , France
Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie
Kassel, Hessen, Germany, Germany
Medizinisches Versorgungszentrum Ãrzteforum Seestrabe
Berlin, , Germany
Ãrzteforum Henningsdorf Darmzentrum Oberhavel
Hennigsdorf, , Germany
Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin
Koeln, Nordrhein Westfalen, , Germany
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie
Wuppertal, , Germany
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BT-CL-PGG-CRC1031
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.