Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00912327 |
Recruitment Status :
Completed
First Posted : June 3, 2009
Last Update Posted : February 15, 2012
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Condition or disease | Intervention/treatment |
---|---|
Colorectal Cancer | Biological: Imprime PGG |
Study Type : | Observational |
Actual Enrollment : | 18 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 Start Date : | June 2009 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |

Group/Cohort | Intervention/treatment |
---|---|
Stage 1 |
Biological: Imprime PGG
Imprime PGG, 4 mg/kg, i.v. over 2 hr, weekly in 6 week cycles and Cetuximab, initial dose will be 400 mg/m2 via i.v., and subsequent doses will be 250 mg/m2 via i.v., weekly in 6 week cycles
Other Name: Erbitux |
Stage 2 |
Biological: Imprime PGG
Imprime PGG, 4 mg/kg, i.v. over 2 hr, weekly in 6 week cycles and Cetuximab, initial dose will be 400 mg/m2 via i.v., and subsequent doses will be 250 mg/m2 via i.v., weekly in 6 week cycles
Other Name: Erbitux |
- Objective response rate (ORR) [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Disease control rate (DCR) and duration of disease control [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Complete response (CR), partial response (PR), and stable disease (SD) rates [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Duration of objective tumor response [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Duration of stable disease [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Time to progression (TTP) [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Progression-free survival (PFS) [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Safety of the dosing regimen [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
- Overall survival [ Time Frame: Assessed after all subjects are deceased or lost to follow-up ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Is >18 years old;
- Has Stage IV carcinoma of the colon or rectum with documented histological or cytological confirmation;
- Tumor has known KRAS mutation;
- Has failed previous irinotecan- and oxaliplatin-containing regimens in either adjuvant or metastatic settings or is intolerant to irinotecan-based therapies;
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
- Has not received any other treatment for colorectal cancer within the 30 days prior to first dose of study treatment under this protocol;
- Has an ECOG score of 0-1;
- Has a life expectancy of > 3 months;
-
Has adequate bone marrow reserve as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- Has adequate renal function as evidenced by serum creatinine ≤ 2.5X the upper limit of normal (ULN) for the reference lab;
-
Has adequate hepatic function as evidenced by:
- AST ≤ 3X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- ALT ≤ 3X ULN for the reference lab (≤ 5X 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/Ethics Committee (IRB/EC); 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 medication (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method).
Exclusion Criteria:
- 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 or suspected brain metastases;
- 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;
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912327
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States | |
United States, New York | |
Memorial Sloane-Kettering Cancer Research Center | |
New York, New York, United States | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States |
Principal Investigator: | Leonard Saltz, MD | Memorial Sloane-Kettering Cancer Center | |
Principal Investigator: | Neil H. Segal, MD, PhD | Memorial Sloane-Kettering Cancer Center | |
Principal Investigator: | Neil Senzer, MD | Mary Crowley Medical Research Center | |
Principal Investigator: | Purvi Gada, MD | University of Minnesota |
Responsible Party: | Biothera |
ClinicalTrials.gov Identifier: | NCT00912327 |
Other Study ID Numbers: |
BT-CL-PGG-CRC0821 |
First Posted: | June 3, 2009 Key Record Dates |
Last Update Posted: | February 15, 2012 |
Last Verified: | February 2012 |
Colorectal KRAS mutation Stage IV |
Imprime PGG Cetuximab Immunotherapy |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |