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Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912327
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Biothera

Tracking Information
First Submitted Date June 1, 2009
First Posted Date June 3, 2009
Last Update Posted Date February 15, 2012
Study Start Date June 2009
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2009)
Objective response rate (ORR) [ Time Frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00912327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 18, 2011)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: June 1, 2009)
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer
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
Brief Summary 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. Subjects will dose until progression of disease or discontinuation from the study for other reasons; e.g., safety, non-compliance. Approximately 56 subjects will be enrolled at three participating centers (17 into Stage 1 and 39 into Stage 2).
Detailed Description 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 data.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor tissue samples from previous biopsies and blood plasma will be collected.
Sampling Method Probability Sample
Study Population Approximately 56 patients with Stage IV Kras-mutated colorectal cancer.
Condition Colorectal Cancer
Intervention 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
Study Groups/Cohorts
  • Stage 1
    Intervention: Biological: Imprime PGG
  • Stage 2
    Intervention: Biological: Imprime PGG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 14, 2012)
18
Original Estimated Enrollment
 (submitted: June 1, 2009)
56
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 metastases)
    2. ALT ≤ 3X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
    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 cetuximab;
  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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00912327
Other Study ID Numbers BT-CL-PGG-CRC0821
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biothera
Study Sponsor Biothera
Collaborators Not Provided
Investigators
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
PRS Account Biothera
Verification Date February 2012