Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
A Phase 1b, Safety, PK, and Efficacy, Multicenter, Dose-Escalating Study of Imprime PGG in Combination With Cetuximab With and Without Irinotecan Therapy in Patients With Recurrent/Progressive Colorectal Carcinoma Following Treatment With a 5-FU Regimen.
1 other identifier
interventional
32
1 country
2
Brief Summary
Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2007
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
March 19, 2025
CompletedMarch 19, 2025
March 1, 2025
2.2 years
October 16, 2007
October 22, 2018
March 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Maximum Tolerated Dosage of Imprime PGG When Used in Combination With Cetuximab With or Without Irinotecan Therapy
Safety and maximum tolerated dosage (MTD) of Imprime PGG was determined by the Adverse Events Task Force based on the drug-related adverse events experienced by subjects that met the criteria for a dose limiting toxicity (DLT) within a timeframe of the first 3 weeks of treatment and 1 week follow-up. If one in the initial three subjects for a dose group experienced a DLT, three additional subjects were enrolled in that dose group. If two or more subjects in the expanded dose group experienced a DLT, the study was to be stopped and the MTD was defined as the dose prior to the dose at which the DLT was observed. If a DLT occurred in the first dose group (2 mg/kg Imprime PGG), the protocol allowed for the next group to be dosed at a reduced dose of 1 mg/kg Imprime PGG. The dose groups described above were: Dose Group 1 (Imprime PGG 2 mg/kg), Dose Group 2 (Imprime PGG 4 mg/kg), Dose Group 3 (Imprime PGG 6 mg/kg).
From the date of the first dose of study drug to disease progression or until development of a drug toxicity that precludes further protocol treatment, up to 15 months
Secondary Outcomes (6)
Rate of Number of Participants With Tumor Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) in Each Study Arm
From the date of the first dose of study drug to disease progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 months
Overall Response Rate (ORR) Per RECIST Criteria v1.0 in Each Study Arm
From the date of the first dose of study drug to disease progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 months
Disease Control Rate (DCR) Per RECIST Criteria v1.0 in Each Study Arm
From the date of the first dose of study drug to disease progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 months
Duration of Time-to-Progression (TTP) in Each Study Arm
The time from the date of the first dose of study drug to the date of the first documented progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 months
Duration of Overall Tumor Response in Each Study Arm
The time from the date of the first dose of study drug to the date of the first documented progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 months
- +1 more secondary outcomes
Study Arms (6)
Imprime PGG 2mg/kg+Cetuximab+Irinotecan
EXPERIMENTALTreatment Arm 1 2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Imprime PGG 4mg/kg+Cetuximab+Irinotecan
EXPERIMENTALTreatment Arm 1 4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Imprime PGG 6mg/kg+Cetuximab+Irinotecan
EXPERIMENTALTreatment Arm 1 6.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Imprime PGG 2mg/kg+Cetuximab
EXPERIMENTALTreatment Arm 2 2.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Imprime PGG 4mg/kg+Cetuximab
EXPERIMENTALTreatment Arm 2 4.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Imprime PGG 6mg/kg+Cetuximab
EXPERIMENTALTreatment Arm 2 6.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Interventions
Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.
Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.
Infusion 400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Infusion 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- Is between the ages of 18 and 75 years old, inclusive;
- Has a recurrent or progressive carcinoma of the colon or rectum with documented histological confirmation of primary carcinoma;
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
- Has a Karnofsky Score of ≥ 70;
- Has a life expectancy of \> 3 months;
- Has adequate bone marrow reserve as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- HGB ≥ 9 g/dl;
- Has adequate renal function as evidenced by serum creatinine ≤ 1.5X the upper limit of normal (ULN) for the reference lab;
- Has adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.0 mg/dL
- AST ≤ 3X ULN for the reference lab (≤ 5X ULN for patients with known hepatic metastases)
- ALT ≤ 3X ULN for the reference lab (≤ 5X ULN for patients with known hepatic metastases);
- Has discontinued any CYP3A4 enzyme-inducing anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) and antimicrobials (such as refampin and rifabutin), St. John's Wort, and ketoconasole at least two weeks prior to Day 1
- +3 more criteria
You may not qualify if:
- Has previously received treatment with cetuximab or irinotecan;
- Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;
- Has a hereditary fructose intolerance;
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection;
- Has had previous exposure to Betafectin® or Imprime PGG;
- Has received previous radiation therapy to \>30% of active bone marrow;
- Has a fever of \>38.5º C within 3 days prior to initial dosing;
- Has known or suspected central nervous system (CNS) 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 or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the investigator's opinion would prevent participation;
- If female, is pregnant or breast-feeding;
- Is receiving concurrent investigational therapy or has received investigational 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HiberCell, Inc.lead
Study Sites (2)
Medical City
Makati City, Philippines
Philippine General Hospital
Manila, Philippines
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michele A. Gargano, MSC/ VP Clin Ops and Prg Mngt
- Organization
- HiberCell
Study Officials
- PRINCIPAL INVESTIGATOR
Ma. Belen Tamayo, MD
The Medical City Hospital
- PRINCIPAL INVESTIGATOR
Gerardo Cornelio, MD, FPCP/FPS
Philippines General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
October 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 19, 2025
Results First Posted
March 19, 2025
Record last verified: 2025-03