Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients
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ClinicalTrials.gov Identifier: NCT02568046 |
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 |
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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 |
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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 |
[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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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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[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) | ||
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) | ||
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) | ||
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) | ||
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 |