Colorectal CancerNCT00912327
Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer
An observational study of Colorectal Cancer, run by HiberCell, Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Imprime PGG
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 56 patients with Stage IV Kras-mutated colorectal cancer.
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mary Crowley Medical Research Center
Dallas, Texas
University of Minnesota
Minneapolis, Minnesota
Memorial Sloane-Kettering Cancer Research Center
New York, New York
About this study
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 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).
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Imprime PGG
- Keywords
- Colorectal, KRAS mutation, Stage IV, Imprime PGG, Cetuximab, Immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imprime PGGBiological
Also called Erbitux
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
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Not described Receives: Biological: Imprime PGG | |
| Stage 2 | Not described Receives: Biological: Imprime PGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Secondary outcomes (8)
Disease control rate (DCR) and duration of disease control
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Complete response (CR), partial response (PR), and stable disease (SD) rates
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Duration of objective tumor response
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Duration of stable disease
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Time to progression (TTP)
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Progression-free survival (PFS)
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Safety of the dosing regimen
Measured: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
Overall survival
Measured: Assessed after all subjects are deceased or lost to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiberCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonard Saltz, MD, Principal investigator, Memorial Sloane-Kettering Cancer CenterNeil H. Segal, MD, PhD, Principal investigator, Memorial Sloane-Kettering Cancer CenterNeil Senzer, MD, Principal investigator, Mary Crowley Medical Research CenterPurvi Gada, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912327
- Sponsor's protocol ID
- BT-CL-PGG-CRC0821
- Status last verified
- Feb 2012
- First submitted
- 1 Jun 2009
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00912327
- Acronym / sponsor ID
- BT-CL-PGG-CRC0821
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal, KRAS mutation, Stage IV, Imprime PGG, Cetuximab, Immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- HiberCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | – | Biological: Imprime PGG |
| Stage 2 | – | Biological: Imprime PGG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 56 patients with Stage IV Kras-mutated colorectal cancer.
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imprime PGGAlso: ErbituxImprime 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 | Biological | Stage 1, Stage 2 |
Primary outcome
Objective response rate (ORR)
Time frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Saltz, MD principal investigator
Memorial Sloane-Kettering Cancer Center
Neil H. Segal, MD, PhD principal investigator
Memorial Sloane-Kettering Cancer Center
Neil Senzer, MD principal investigator
Mary Crowley Medical Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by HiberCell, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Assessed after 17 subjects complete 1 treatment cycle and at completion of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2012.