Colorectal CancerPhase 3PRIMUSNCT01309126
Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
A Phase 3 study testing Imprime PGG + cetuximab and Cetuximab in people with Colorectal Cancer, run by HiberCell, Inc. at 53 sites in 4 countries.
Trial summary
Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. 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 + cetuximab and Cetuximab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 53 sitesin 4 countries
- Study dates
- Apr 2011to Feb 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Is >18 years old;
- Has recurrent or metastatic carcinoma of the colon or rectum with documented histological or cytological confirmation;
- Must be KRAS WT;
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1;
- 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;
- Has an Eastern Cooperative Oncology Group (ECOG) score of 0-1, with a life expectancy of >3 months;
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- Has received at least 2 prior chemotherapeutic regimens for colorectal cancer;
- Has adequate bone marrow reserve as evidenced by:
- Absolute neutrophil count ≥1,500/μL
- Platelets ≥100,000/μL;
- Has adequate renal function as evidenced by serum creatinine ≤2.5 × the upper limit of normal (ULN) for the reference lab;
- 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
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC); 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 drug (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 untreated or symptomatic brain metastases;
- 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;
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- 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;
- 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
53 sites in 4 countries.
53 sites in 4 countries
United States44 sites
Texas Oncology-Amarillo
Amarillo, Texas, 79106
Pacific Medical Center
Anaheim, California, 92801
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Indiana University Cancer Center
Beech Grove, Indiana, 46237
Highlands Oncology Group
Bentonville, Arkansas, 72703
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Providence St. Joseph Medical Center
Burbank, California, 91505
Ellis Fischel Cancer Center at University of Missouri- Columbia
Columbia, Missouri, 65203
Mary Crowley Cancer Research Center
Dallas, Texas, 75201
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology Denton South
Denton, Texas, 76210
Henry Ford Health System
Detroit, Michigan, 48202
Hematology and Oncology Associates of Central NY
East Syracuse, New York, 13057
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Northwest Alabama Cancer Center
Florence, Alabama, 35630
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104
Medical and Surgical Specialists
Galesburg, Illinois, 61401
The Jones Clinic
Germantown, Tennessee, 38138
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
New York Oncology, Hematology, P.C.
Hudson, New York, 12534
Tennessee Cancer Specialists
Knoxville, Tennessee, 37915
UCSD Moores Cancer Center
La Jolla, California, 92903
Texas Oncology - Lewisville
Lewisville, Texas, 75067
Kenmar Research Institute
Los Angeles, California, 90057
University of Louisville/James Brown Cancer Center
Louisville, Kentucky, 40202
AMPM Research Clinic
Miami Gardens, Florida, 33169
Signal Point Hematology/Oncology
Middletown, Ohio, 45042
University of Minnesota
Minneapolis, Minnesota, 55455
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Virginia Oncology Associates
Newport News, Virginia, 23606
Illinois Cancer Specialists
Niles, Illinois, 60714
Northern Utah Associates
Ogden, Utah, 84403
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
MD Anderson Cancer Center
Orlando, Florida, 32806
Providence Portland Medical Center
Portland, Oregon, 97213
Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Texas Oncology-Seton Williamson
Round Rock, Texas, 78665
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Texas Oncology - Sherman
Sherman, Texas, 75090
Cancer Centers of the Carolinas
Spartanburg, South Carolina, 29307
Toledo Community Oncology Program- Toledo Community Hospital
Toledo, Ohio, 43623
Texas Oncology - Tyler
Tyler, Texas, 75702
Germany7 sites
Medizinisches Versorgungszentrum Ãrzteforum Seestrabe
Berlin, 13347
Ãrzteforum Henningsdorf Darmzentrum Oberhavel
Hennigsdorf, 16761
Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie
Kassel, Hessen, Germany, 34125
Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin
Koeln, Nordrhein Westfalen, 50937
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, 39104
Universitaetsklinikum Ulm
Ulm, 89081
Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie
Wuppertal, 42283
About this study
Official title: 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 wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- Imprime PGG + cetuximab, Cetuximab
- Keywords
- Colorectal Cancer, KRAS Wild Type, Imprime PGG, Cetuximab, Phase 3, Efficacy, Safety, Recurrent or Progressive KRAS Wild Type Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imprime PGG + cetuximabBiological
Also called Imprime PGG, Cetuximab (Erbitux)
Imprime PGG: 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 Cetuximab: initial dose 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)
CetuximabDrug
Also called Cetuximab (Erbitux)
Cetuximab: initial dose 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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Imprime PGG + cetuximab | Experimental | Biological/Vaccine + Drug Receives: Biological: Imprime PGG + cetuximab |
| Arm 2: cetuximab | Active comparator | Drug Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: 18 months
Secondary outcomes (7)
Progression Free Survival (PFS)
Measured: 18 months
Rate of complete response (CR)
Measured: 18 months
Rate of partial response (PR)
Measured: 18 months
Rate of overall response (CR + PR)
Measured: 18 months
Safety and tolerability of the dosing regimen as measured by the incidence and severity of adverse events observed in study participants
Measured: 18 months
Sparse pharmacokinetic profile of Imprime PGG will be determined to expand current Imprime PGG PK data
Samples for sparse PK will be taken at specified times on Cycle 1/Day 1 in the first 30 available subjects randomized to Arm 1 (Subjects 1-30). Samples will be collected, at multiple times, in the next 60 subjects randomized to Arm 1 who reach Cycle 2/Day 1 of dosing (subjects 31-90). Additionally, any subject after the first 90 subjects (subjects 91-795) who have a screening/baseline calculated creatinine clearance (based on age, weight and serum creatinine) of <60 mL/minute will have sparse PK samples collected.
Measured: 18 months
Change in Quality of Life
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Due to enrollment challenges resulting from changing treatment patterns in the use of cetuximab, the study has been terminated. No patients remain on study.
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiberCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309126
- Sponsor's protocol ID
- BT-CL-PGG-CRC1031
- Acronym
- PRIMUS
- Status last verified
- Jul 2017
- First submitted
- 8 Feb 2011
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01309126
- Acronym / sponsor ID
- PRIMUS / BT-CL-PGG-CRC1031
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, KRAS Wild Type, Imprime PGG, Cetuximab, Phase 3, Efficacy, Safety, Recurrent or Progressive KRAS Wild Type Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to enrollment challenges resulting from changing treatment patterns in the use of cetuximab, the study has been terminated. No patients remain on study.
- Enrolment
- 217 participants (actual)
- Lead sponsor
- HiberCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 Mar 2011 (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-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Imprime PGG + cetuximab | Experimental | Biological: Imprime PGG + cetuximabBiological/Vaccine + Drug |
| Arm 2: cetuximab | Active comparator | Drug: CetuximabDrug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Is >18 years old;
- Has recurrent or metastatic carcinoma of the colon or rectum with documented histological or cytological confirmation;
- Must be KRAS WT;
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1;
- 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;
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 untreated or symptomatic 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 PGG + cetuximabAlso: Imprime PGG, Cetuximab (Erbitux)Imprime PGG: 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 Cetuximab: initial dose 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) | Biological | Arm 1: Imprime PGG + cetuximab |
| CetuximabAlso: Cetuximab (Erbitux)Cetuximab: initial dose 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) | Drug | Arm 2: cetuximab |
Primary outcome
Overall Survival (OS)
Time frame: 18 months
7 secondary outcomes
Progression Free Survival (PFS)
Time frame: 18 months
Rate of complete response (CR)
Time frame: 18 months
Rate of partial response (PR)
Time frame: 18 months
Rate of overall response (CR + PR)
Time frame: 18 months
Safety and tolerability of the dosing regimen as measured by the incidence and severity of adverse events observed in study participants
Time frame: 18 months
Sparse pharmacokinetic profile of Imprime PGG will be determined to expand current Imprime PGG PK data
Time frame: 18 months
Change in Quality of Life
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Due to enrollment challenges resulting from changing treatment patterns in the use of cetuximab, the study has been terminated. No patients remain on study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imprime PGG + cetuximab and Cetuximab in people with Colorectal Cancer, run by HiberCell, Inc. at 53 sites in 4 countries.
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 18 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: stopped early, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Germany, France, Puerto Rico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to enrollment challenges resulting from changing treatment patterns in the use of cetuximab, the study has been terminated. No patients remain on study.). Results are not available in the source record.
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?
Overall Survival (OS) (time frame: 18 months). 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 13 Jul 2017.