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

Stopped early · Phase 3

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID: NCT01309126
Run by: HiberCell, Inc.
People needed: 217
Starts: 2011-04-01
Expected to finish: 2017-02-01
Last updated by the study team: 2017-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Is >18 years old;
Has recurrent or metastatic carcinoma of the colon or rectum with documented histological or cytological confirmation;
Must be KRAS WT;
Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1;
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;
Has an Eastern Cooperative Oncology Group (ECOG) score of 0-1, with a life expectancy of >3 months;
Has received at least 2 prior chemotherapeutic regimens for colorectal cancer;
Has adequate bone marrow reserve as evidenced by:
Absolute neutrophil count ≥1,500/μL
Platelets ≥100,000/μL;
Has adequate renal function as evidenced by serum creatinine ≤2.5 × the upper limit of normal (ULN) for the reference lab;
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
Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC); and
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).

You may not qualify if…

Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;
Has a known hypersensitivity to baker's yeast or has an active yeast infection;
Has had previous exposure to Betafectin® or Imprime PGG;
Has an active, uncontrolled infection;
Has known untreated or symptomatic brain metastases;
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;
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;
If female, is pregnant or breast-feeding;
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
Has previously received an organ or progenitor/stem cell transplant.

Where it is running

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
Northwest Alabama Cancer Center — Florence, Alabama, United States

Full record on ClinicalTrials.gov

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