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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

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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 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.

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Time Frame:

18 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

September 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer
  • KRAS Wild Type
  • Imprime PGG
  • Cetuximab
  • Phase 3
  • Efficacy
  • Safety
  • Recurrent or Progressive KRAS Wild Type Colorectal Cancer
  • Colorectal Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Virginia Oncology Associates Newport News, Virginia  23606
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Carle Cancer Center Urbana, Illinois  61801
Comprehensive Blood and Cancer Center Bakersfield, California  93309
University of Minnesota Minneapolis, Minnesota  55455
Highlands Oncology Group Springdale, Arkansas  72764
Tennessee Cancer Specialists Knoxville, Tennessee  37920
Kenmar Research Institute Los Angeles, California  90057
Northern Utah Associates Ogden, Utah  84403
Henry Ford Health System Detroit, Michigan  48202
Dana Farber Cancer Institute Boston, Massachusetts  02115
Providence Portland Medical Center Portland, Oregon  97213-3635
Providence St. Joseph Medical Center Burbank, California  91505
UCSD Moores Cancer Center La Jolla, California  93093
The Jones Clinic Germantown, Tennessee  38138
Medical and Surgical Specialists Galesburg, Illinois  61401
Puget Sound Cancer Centers Edmonds, Washington  98026
Cancer Care Centers of South Texas San Antonio, Texas  78229
Signal Point Hematology/Oncology Middletown, Ohio  45042
Texas Oncology-Seton Williamson Round Rock, Texas  78665
Mary Crowley Cancer Research Center Dallas, Texas  75246
Willamette Valley Cancer Institute and Research Center Springfield, Oregon  97477
Texas Oncology - Tyler Tyler, Texas  75702
University of Hawaii Cancer Center Honolulu, Hawaii  96813
Illinois Cancer Specialists Niles, Illinois  60714
Texas Oncology - Fort Worth Fort Worth, Texas  76104
Texas Oncology - Lewisville Lewisville, Texas  75067
Texas Oncology - Dallas Presbyterian Hospital Dallas, Texas  75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas  75246
Texas Oncology - Sherman Sherman, Texas  75090-0504
Pacific Medical Center San Francisco, California  
National Institute of Clinical Research (Lalita Pandit, MN Inc.) Fountain Valley, California  92708
University of Louisville/James Brown Cancer Center Louisville, Kentucky  40202
Ellis Fischel Cancer Center at University of Missouri- Columbia Columbia, Missouri  65203
Gabrail Cancer Centr Research Canton, Ohio  44718
Toledo Community Oncology Program- Toledo Community Hospital Toledo, Ohio  43623
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Salem, Virginia  24153
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha, Nebraska  68130
New York Oncology, Hematology, P.C. Hudson, New York  12534
Texas Oncology-Amarillo Amarillo, Texas  79106