Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients
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| ClinicalTrials.gov Identifier: NCT02568046 |
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Recruitment Status :
Terminated
(Discontinued development of Sym004 in combination with FOLFIRI)
First Posted : October 5, 2015
Results First Posted : January 9, 2019
Last Update Posted : March 26, 2019
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Metastatic Colorectal Cancer |
| Interventions |
Drug: Sym004 Drug: FOLFIRI |
| Enrollment | 10 |
| Recruitment Details | The first patient was enrolled in March 2016. In January 2017, the trial was terminated early and enrollment was prematurely discontinued. |
| Pre-assignment Details |
| Arm/Group Title | Dose Level 1: Sym004 12 mg/kg + FOLFIRI | Dose Level -1: Sym004 9 mg/kg + FOLFIRI |
|---|---|---|
 Arm/Group Description |
Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR). The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours). |
Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR). The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours). |
| Period Title: Overall Study | ||
| Started | 5 | 5 |
| Completed [1] | 0 | 2 |
| Not Completed | 5 | 3 |
| Reason Not Completed | ||
| Adverse Event | 0 | 1 |
| Death | 2 | 0 |
| Progressive Disease | 1 | 0 |
| Withdrawal by Subject | 2 | 1 |
| Other Events | 0 | 1 |
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[1]
Two (2) patients were ongoing at the time of data cut-off for Primary Completion.
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| Arm/Group Title | Dose Level 1: Sym004 12 mg/kg + FOLFIRI | Dose Level -1: Sym004 9 mg/kg + FOLFIRI | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR). The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours). |
Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR). The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours). |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 5 | 5 | 10 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| 69.3 (8.55) | 61.1 (9.95) | 65.2 (9.76) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| Female |
2 40.0%
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2 40.0%
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4 40.0%
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| Male |
3 60.0%
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3 60.0%
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6 60.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| Hispanic or Latino |
1 20.0%
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2 40.0%
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3 30.0%
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| Not Hispanic or Latino |
4 80.0%
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3 60.0%
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7 70.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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0 0.0%
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0 0.0%
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|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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|
| Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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| White |
5 100.0%
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5 100.0%
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10 100.0%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 5 participants | 5 participants | 10 participants |
| United States |
3 60.0%
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2 40.0%
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5 50.0%
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| Spain |
2 40.0%
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3 60.0%
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5 50.0%
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Height
Mean (Standard Deviation) Unit of measure: Centimeters (cm) |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| 170.4 (8.57) | 171.3 (4.47) | 170.9 (6.46) | ||
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Weight
Mean (Standard Deviation) Unit of measure: Kilograms (kg) |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| 76.6 (11.97) | 82.5 (16.10) | 79.6 (13.73) | ||
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Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| 26.5 (4.20) | 28.0 (4.52) | 27.3 (4.19) | ||
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Body Surface Area (BSA)
Mean (Standard Deviation) Unit of measure: M^2 |
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| Number Analyzed | 5 participants | 5 participants | 10 participants | |
| 1.9 (0.17) | 2.0 (0.24) | 1.9 (0.20) | ||
| Name/Title: | Chief Scientific Officer |
| Organization: | Symphogen A/S |
| Phone: | +45 8838 2600 |
| EMail: | info@symphogen.com |
| Responsible Party: | Symphogen A/S |
| ClinicalTrials.gov Identifier: | NCT02568046 |
| Other Study ID Numbers: |
Sym004-09 2015-003047-19 ( EudraCT Number ) |
| First Submitted: | September 30, 2015 |
| First Posted: | October 5, 2015 |
| Results First Submitted: | December 19, 2018 |
| Results First Posted: | January 9, 2019 |
| Last Update Posted: | March 26, 2019 |