Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGGâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imprime PGG 2mg/kg+Cetuximab+Irinotecan | Experimental | Treatment Arm 1 2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. |
|
| Imprime PGG 4mg/kg+Cetuximab+Irinotecan | Experimental | Treatment Arm 1 4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. |
|
| Imprime PGG 6mg/kg+Cetuximab+Irinotecan | Experimental | Treatment Arm 1 6.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. |
|
| Imprime PGG 2mg/kg+Cetuximab | Experimental | Treatment Arm 2 2.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab. |
|
| Imprime PGG 4mg/kg+Cetuximab | Experimental | Treatment Arm 2 4.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imprime PGG 2 mg/kg | Biological | Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
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;
Has adequate bone marrow reserve as evidenced by:
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:
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).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ma. Belen Tamayo, MD | The Medical City Hospital | Principal Investigator |
| Gerardo Cornelio, MD, FPCP/FPS | Philippines General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical City | Makati City | Philippines | ||||
| Philippine General Hospital |
A total of 32 participants enrolled, all participants received at least one dose of study treatment.
A phase 1b/2 dose-escalating (ascending dose model) design with 10 subjects enrolled in stage 1, 22 additional subjects in stage 2, for a total of 32 subjects enrolled sequentially into two treatment arms across Southeast Asia clinical sites.
First subject enrolled: 15 Oct 2007 Last subject last visit: 04 Nov 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Imprime PGG 6mg/kg+Cetuximab | Experimental | Treatment Arm 2 6.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab. |
|
| Imprime PGG 4 mg/kg | Biological | Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Cetuximab | Biological | 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; |
|
| Irinotecan | Drug | 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/kg | Biological | Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops. |
|
| 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 | 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. | 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 | 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. | 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 | 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). | 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 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). | 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 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). | 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 |
| Manila |
| Philippines |
| FG001 | Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| FG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| FG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| FG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| FG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| Discontinued |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population comprised all subjects who received any amount of Imprime PGG.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| BG001 | Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| BG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| BG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| BG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| BG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Baseline Karnofsky Performance Status Score | Karnofsky Performance Status Score: 100-Normal no complaints; no evidence of disease 90-Carry on normal activity; minor signs of disease 80-Normal activity with effort; some signs of disease 70-Cares for self; unable to carry on normal activity or active work 60-Requires occasional assistance, can care for personal needs 50-Requires considerable assistance & frequent medical care 40-Disabled; requires assistance 30-Severely disabled; hospital admission indicated 20-Very sick; hospital admission & supportive treatment necessary 10-Moribund; fatal process progressing rapidly 0-Dead | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Baseline Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Baseline Body Surface Area | Mean | Standard Deviation | m^2 |
| |||||||||||||||
| Time Since Initial Tumor Diagnosis | Mean | Standard Deviation | days |
| |||||||||||||||
| Initial Pathologic Diagnosis | Number | participants |
| ||||||||||||||||
| Basis of Diagnosis | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The safety population comprised of all subjects who received any amount of Imprime PGG. | Posted | Number | participants | 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 | 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. | The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations. | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations. | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations. | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations. | Posted | Median | 95% Confidence Interval | days | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations. | Posted | Median | Full Range | days | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations. | Posted | Median | 95% Confidence Interval | days | 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 |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle | 3 | 3 | 3 | 3 | ||
| EG001 | Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle | 6 | 7 | 7 | 7 | ||
| EG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle | 0 | 0 | 0 | 0 | ||
| EG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 | 2 | 4 | 4 | 4 | ||
| EG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 | 4 | 9 | 9 | 9 | ||
| EG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 | 2 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Perianal abscess | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hepatic mass | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| International normalized ratio increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Familial periodic paralysis | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Leukpoenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Otitis externa | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Conjunctival cyst | Eye disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ocular surface disease | Eye disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Mucosal inflammation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Perianal abscess | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Generalized muscle ache | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Procedural pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Viceral oedema | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Alanine amniotransferase decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Alanine amniotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Asparate amniotransferase decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Asparate amniotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood amylase decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood bicarbonate increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood magnesium increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood urea decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood urea nitrogen/creatinine ratio decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Creatine phosphokinase decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Electrocardiogram poor r-wave progression | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Gammaglutamyltransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Globulins increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Protein total increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nitrate urine present | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Genital haemorhage | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Carbuncle | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dermatits acneform | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Excoriation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Palmar-plantar erythordysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Paronychia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Phelbitis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele A. Gargano, MSC/ VP Clin Ops and Prg Mngt | HiberCell | 651.675.0300 | mgargano@hibercell.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002277 | Carcinoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Rectum Carcinoma |
|
| Histology |
|
| OG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| Subjects Who Discontinued the Study |
|
| OG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| OG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
|
|
| OG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| OG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
|
|
| OG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| OG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
|
|
| OG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| OG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
|
|
| OG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| OG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
|
|
Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| OG002 | Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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; Irinotecan infusion: 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle |
| OG003 | Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab | Imprime PGG® infusion: 2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG004 | Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab | Imprime PGG® infusion: 4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
| OG005 | Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab | Imprime PGG® infusion: 6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle; Cetuximab 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 |
|
|