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Recurrent Colorectal CarcinomaPhase 1/2NCT00545545

Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma

A Phase 1/2 study testing Imprime PGG 2 mg/kg, Imprime PGG 4 mg/kg and Cetuximab in people with Recurrent Colorectal Carcinoma and Progressive Colorectal Carcinoma, run by HiberCell, Inc. at 2 sites in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Imprime PGG 2 mg/kg, Imprime PGG 4 mg/kg and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesPhilippines
Study dates
Oct 2007to Dec 2009
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 previously received treatment with 5-FU, alone or in combination with other anti-tumor medications (except as in exclusion #1 below); Prior treatment with capecitabine (Xeloda®) will be considered to fulfill the requirement for prior treatment with 5-FU;
  • Has a Karnofsky Score of ≥ 70;
  • Has a life expectancy of > 3 months;
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  • 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
  • Has recovered from the effects of any prior surgery, radiotherapy, or chemotherapy;
  • Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC); and
  • If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception during the study and for 120 days following the last dose of study medication (an effective form of contraception is an hormonal contraceptive or a double-barrier method).

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Philippines2 sites

  • Medical City

    Makati City

  • Philippine General Hospital

    Manila

Other trials in Philippines

About this study

Official title: 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.

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.

Being tested
Imprime PGG 2 mg/kg, Imprime PGG 4 mg/kg, Cetuximab, Irinotecan, Imprime PGG 6mg/kg
Keywords
Colorectal, Carcinoma, Recurrent, Progressive, Cetuximab, Irinotecan, 5-Fluorouracil
Medical subject headings
Colorectal Neoplasms, Carcinoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imprime PGG 2 mg/kgBiological

    Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.

  • Imprime PGG 4 mg/kgBiological

    Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.

  • CetuximabBiological

    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;

  • IrinotecanDrug

    Infusion 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle

  • Imprime PGG 6mg/kgBiological

    Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.

Study groups in NCT00545545
Study groupRoleWhat they receive
Imprime PGG 2mg/kg+Cetuximab+IrinotecanExperimentalTreatment Arm 1 2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Receives: Biological: Imprime PGG 2 mg/kg; Biological: Cetuximab; Drug: Irinotecan
Imprime PGG 4mg/kg+Cetuximab+IrinotecanExperimentalTreatment Arm 1 4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Receives: Biological: Imprime PGG 4 mg/kg; Biological: Cetuximab; Drug: Irinotecan
Imprime PGG 6mg/kg+Cetuximab+IrinotecanExperimentalTreatment Arm 1 6.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Receives: Biological: Cetuximab; Drug: Irinotecan; Biological: Imprime PGG 6mg/kg
Imprime PGG 2mg/kg+CetuximabExperimentalTreatment Arm 2 2.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Receives: Biological: Imprime PGG 2 mg/kg; Biological: Cetuximab
Imprime PGG 4mg/kg+CetuximabExperimentalTreatment Arm 2 4.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Receives: Biological: Imprime PGG 4 mg/kg; Biological: Cetuximab
Imprime PGG 6mg/kg+CetuximabExperimentalTreatment Arm 2 6.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Receives: Biological: Cetuximab; Biological: Imprime PGG 6mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. 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

    The best observed overall response rates were defined as the number of participants experiencing a best tumor response of either complete response (CR; disappearance of all target lesions), partial response (PR; >=30% decrease in the sum of diameters of target lesions), stable disease (SD) or progressive disease (PD) based on RECIST criteria v1.0.

    Measured: 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

  2. Overall Response Rate (ORR) Per RECIST Criteria v1.0 in Each Study Arm

    The overall response rate was defined as the number of participants experiencing a best tumor response of either complete response (CR; disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of diameters of target lesions) based on RECIST criteria v.1.0. Overall response rate (ORR) = CR + PR.

    Measured: 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

  3. Disease Control Rate (DCR) Per RECIST Criteria v1.0 in Each Study Arm

    The disease control rate was defined as the number of participants experiencing a best tumor response of either complete response (CR; disappearance of all target lesions), partial response (PR; >=30% decrease in the sum of diameters of target lesions) or stable disease (SD) based on RECIST criteria v.1.0. Disease control rate (DCR) = CR + PR + SD.

    Measured: 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

  4. Duration of Time-to-Progression (TTP) in Each Study Arm

    Time-to-progression (TTP) was defined as the time from the date of the first dose of study drug to the date of the first documented progression (date of the CT scan where progression was first observed; or where progression was first observed if clinical assessment). Subjects who did not progress were censored at the last objective evaluation (the date of the last CT scan; or last observed clinical assessment).

    Measured: 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

  5. Duration of Overall Tumor Response in Each Study Arm

    The duration of objective tumor response was defined as the time from the date of the first documented CT scan showing CR (disappearance of all target lesions) or PR (>=30% decrease in the sum of diameters of target lesions), whichever occurred first, to the date of the first documented progression (date of CT scan where PD was first observed; or where progression was first observed if based on a clinical assessment).

    Measured: 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

  6. Duration of Disease Control in Each Study Arm

    Duration of stable disease (SD) was to be an efficacy variable, however, duration of disease control was used in place of duration of stable disease, as it is a more clinically meaning measure of the effectiveness of the treatment. Duration of disease control was defined as the time from the date of the first documented CT scan showing CR (disappearance of all target lesions), PR (>=30% decrease in the sum of diameters of target lesions) or SD, whichever occurred first, to the date of the first documented progression (date of CT scan where PD was first observed; or where progression was first observed if based on a clinical assessment).

    Measured: The time from the date of first dose of study drug to the date of first documented progression, or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00545545
Sponsor's protocol ID
BT-CL-PGG-CRC0713
Status last verified
Mar 2025
First submitted
16 Oct 2007
Last updated
19 Mar 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Imprime PGG 2 mg/kg, Imprime PGG 4 mg/kg and Cetuximab in people with Recurrent Colorectal Carcinoma and Progressive Colorectal Carcinoma, run by HiberCell, Inc. at 2 sites in Philippines.

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 13 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Philippines. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety and Maximum Tolerated Dosage of Imprime PGG When Used in Combination With Cetuximab With or Without Irinotecan Therapy (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00545545.

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 19 Mar 2025.

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