A Study of Aflibercept Versus Placebo With FOLFIRI in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin Chemotherapy (AFLAME)
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| ClinicalTrials.gov Identifier: NCT01661270 |
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Recruitment Status :
Completed
First Posted : August 9, 2012
Results First Posted : November 26, 2015
Last Update Posted : October 18, 2016
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Colorectal Cancer Metastatic |
| Interventions |
Drug: Aflibercept Drug: Placebo |
| Enrollment | 332 |
Participant Flow
| Recruitment Details | The study was conducted at 37 centers in 5 countries. A total of 332 participants were randomized between 17 July 2012 and 18 March 2014. |
| Pre-assignment Details |
Due to treatment kit misallocation, part of the patients randomized to placebo received aflibercept for 1/several treatment cycles and are presented as a separate group for safety evaluation. EOT criteria were: disease progression/death, un-tolerable toxicity, consent withdrawal/Investigator decision. |
| Arm/Group Title | Placebo | Aflibercept |
|---|---|---|
 Arm/Group Description |
Placebo for aflibercept intravenous (IV) infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2. | Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2. |
| Period Title: Overall Study | ||
| Started | 109 | 223 |
| Adverse Event | 26 [1] | 47 [2] |
| Disease Progression | 67 [2] | 118 [2] |
| Physician Decision | 1 [2] | 8 [2] |
| Participant's Request | 15 [2] | 48 [2] |
| Other Reasons | 0 | 2 |
| Completed | 109 [3] | 223 [3] |
| Not Completed | 0 | 0 |
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[1]
Met end of treatment (EOT) criteria.
[2]
Met EOT criteria
[3]
Treatment until disease progression/death, toxicity, consent withdrawal or Investigator's decision.
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Baseline Characteristics
| Arm/Group Title | Placebo | Aflibercept | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2. | Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 109 | 223 | 332 | |
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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 | 109 participants | 223 participants | 332 participants | |
| 53.0 (11.3) | 55.1 (10.9) | 54.4 (11.0) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 109 participants | 223 participants | 332 participants | |
| Female |
46 42.2%
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95 42.6%
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141 42.5%
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| Male |
63 57.8%
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128 57.4%
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191 57.5%
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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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01661270 |
| Other Study ID Numbers: |
EFC11338 U1111-1115-7227 ( Other Identifier: UTN ) |
| First Submitted: | August 7, 2012 |
| First Posted: | August 9, 2012 |
| Results First Submitted: | October 22, 2015 |
| Results First Posted: | November 26, 2015 |
| Last Update Posted: | October 18, 2016 |