Trial record 1 of 1 for:
efc11885
A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan
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ClinicalTrials.gov Identifier: NCT01882868 |
Recruitment Status :
Completed
First Posted : June 20, 2013
Results First Posted : March 14, 2017
Last Update Posted : March 14, 2017
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Colorectal Cancer Metastatic |
Interventions |
Drug: Aflibercept Drug: Levofolinate Drug: Irinotecan Drug: 5-FU |
Enrollment | 62 |
Participant Flow
Recruitment Details | The study was conducted at 19 sites in Japan. A total of 68 participants were screened between 30 July 2013 and 12 March 2014, out of which 62 were enrolled and treated. |
Pre-assignment Details | Among 68 participants screened, 6 were screen failures due to elevated urine protein-creatinine ratio (UPCR) and inadequate liver function tests (LFTs). |
Arm/Group Title | Aflibercept + FOLFIRI |
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Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2. |
Period Title: Overall Study | |
Started | 62 |
Completed | 62 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Aflibercept + FOLFIRI | |
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Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2. | |
Overall Number of Baseline Participants | 60 | |
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Evaluable participant (EP) population: all registered participants with measurable disease at study entry & with at least 1 valid post-baseline tumor evaluation. Participants who died due to DP or had documented radiological progressive disease before first post-baseline imaging evaluation were also included.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 60 participants | |
61.6 (9.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 60 participants | |
Female |
26 43.3%
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Male |
34 56.7%
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Eastern Cooperative Oncology Group Performance Status (ECOG PS)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 60 participants |
0 | 40 | |
1 | 20 | |
[1]
Measure Description: ECOG PS is used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead.
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Prior Treatment with Bevacizumab
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 60 participants |
Had Prior Treatment | 50 | |
Did Not Have Prior Treatment | 10 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi |
EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01882868 |
Other Study ID Numbers: |
EFC11885 U1111-1120-0173 ( Other Identifier: UTN ) |
First Submitted: | June 18, 2013 |
First Posted: | June 20, 2013 |
Results First Submitted: | August 26, 2016 |
Results First Posted: | March 14, 2017 |
Last Update Posted: | March 14, 2017 |