Trial record 1 of 1 for:
AFLIBL06266
Colorectal Cancer Metastatic (AFEQT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01670721 |
Recruitment Status :
Completed
First Posted : August 22, 2012
Results First Posted : November 28, 2016
Last Update Posted : November 28, 2016
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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: Irinotecan Drug: Fluorouracil Drug: Leucovorin |
Enrollment | 175 |
Participant Flow
Recruitment Details | The study was conducted at 38 sites in France. A total of 182 participants were screened between 08 August 2012 and 30 June 2014, out of which 175 participants were enrolled and treated. |
Pre-assignment Details | Participants enrolled in the study to assess the safety of Aflibercept in participants treated with a combination of Aflibercept with FOLFIRI regimen (Irinotecan, Leucovorin and 5-Fluorouracil [5-FU]). |
Arm/Group Title | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) |
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Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment. |
Period Title: Overall Study | |
Started | 175 |
Completed | 122 [1] |
Not Completed | 53 |
Reason Not Completed | |
Participant's decision | 15 |
Other than specified above | 38 |
[1]
81 participants with DP and 41 with adverse events were considered as completed.
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Baseline Characteristics
Arm/Group Title | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | |
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Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment. | |
Overall Number of Baseline Participants | 175 | |
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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 | 175 participants | |
64.5 (11.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 175 participants | |
Female |
77 44.0%
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Male |
98 56.0%
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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 |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01670721 |
Other Study ID Numbers: |
AFLIBL06266 2012-000048-89 U1111-1128-9325 ( Other Identifier: UTN ) |
First Submitted: | July 13, 2012 |
First Posted: | August 22, 2012 |
Results First Submitted: | June 8, 2016 |
Results First Posted: | November 28, 2016 |
Last Update Posted: | November 28, 2016 |