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A Phase 2 Efficacy and Safety, Open-label, Multicenter Study of Imprime PGG® Injection in Combination With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer

18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Phase 2 Efficacy and Safety, Open-label, Multicenter Study of Imprime PGG® Injection in Combination With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer

Study BT-CL-PGG-CRC0821 is a Phase 2, open-label, multicenter, efficacy and safety study. It
will be conducted using a two-stage design with the intention of determining the initial
efficacy of Imprime PGG in combination with a monoclonal antibody (MAb; cetuximab) in the
treatment of KRAS-mutant colorectal cancer (CRC). Both stages will be conducted in subjects
with Stage IV CRC demonstrating the KRAS gene mutation. All subjects will receive Imprime
PGG at 4 mg/kg and standard doses of cetuximab; Imprime PGG and cetuximab will be
administered in 6-week cycles. Subjects will dose until progression of disease or
discontinuation from the study for other reasons; e.g., safety, non-compliance. The initial
cetuximab dose will be 400 mg/m2 on Cycle 1/Day1 and subsequent doses of cetuximab will be
250 mg/m2 weekly. Imprime PGG will be dosed weekly at 4 mg/kg. Tumor measurements and
determination of tumor responses for this study will be performed according to RECIST.
Approximately 56 subjects will be enrolled at three participating centers (17 into Stage 1
and 39 into Stage 2). Final results will be determined from combined Stage 1 and Stage 2

Inclusion Criteria:

1. Is >18 years old;

2. Has Stage IV carcinoma of the colon or rectum with documented histological or
cytological confirmation;

3. Tumor has known KRAS mutation;

4. Has failed previous irinotecan- and oxaliplatin-containing regimens in either
adjuvant or metastatic settings or is intolerant to irinotecan-based therapies;

5. Has measurable disease, defined as at least one tumor that fulfills the criteria for
a target lesion according to RECIST;

6. Has not received any other treatment for colorectal cancer within the 30 days prior
to first dose of study treatment under this protocol;

7. Has an ECOG score of 0-1;

8. Has a life expectancy of > 3 months;

9. Has adequate bone marrow reserve as evidenced by:

1. ANC ≥ 1,500/μL

2. PLT ≥ 100,000/μL

10. Has adequate renal function as evidenced by serum creatinine ≤ 2.5X the upper limit
of normal (ULN) for the reference lab;

11. Has adequate hepatic function as evidenced by:

1. AST ≤ 3X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic

2. ALT ≤ 3X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic

3. Bilirubin < 1.5 mg/dl, OR direct bilirubin < 1.0 mg/dl

4. Serum Albumin > 3.0 gm/dl

12. Has read, understood and signed the informed consent form (ICF) approved by the
Independent Review Board/Ethics Committee (IRB/EC); and

13. 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 medication (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 or suspected brain metastases;

6. Had a second malignancy within the previous 5 years, except for basal cell carcinoma,
cervical intra-epithelial neoplasia or curatively-treated prostate cancer with a PSA
of < 2.0 ng/mL;

7. Has known HIV/AIDS, Hepatitis B, Hepatitis C, connective tissue disease, or other
clinical diagnosis, ongoing or intercurrent illness that in the investigator's
opinion should prevent 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:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Objective response rate (ORR)

Outcome Time Frame:

Assessed after 17 subjects complete 1 treatment cycle and at completion of study.

Safety Issue:


Principal Investigator

Leonard Saltz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloane-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

February 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal
  • KRAS mutation
  • Stage IV
  • Imprime PGG
  • Cetuximab
  • Immunotherapy
  • Colorectal Neoplasms



University of Minnesota Minneapolis, Minnesota  55455
Mary Crowley Medical Research Center Dallas, Texas  75246
Memorial Sloane-Kettering Cancer Research Center New York, New York