TriangleNCT00561470 · STUDY IN CONTEXT
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.
The overall ORR was the percentage of evaluable participants who achieved complete response \[CR\] or partial response \[PR\] according to RECIST criteria version 1.0. * CR reflected the disappearance of all tumor lesions (with no new tumors) * PR reflected a pre-defined reduction in tumor burden Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.
All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.
Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- trial label
- Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 5
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0000
- source section id
- NCT00561470-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
- time origin
- From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat population (ITT) - all participants who gave informed consent and were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0001
- source section id
- NCT00561470-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
- endpoint definition
- PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.
- time origin
- From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0002
- source section id
- NCT00561470-om-0002
- source outcome index
- 2
- endpoint
- Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
- endpoint definition
- The overall ORR was the percentage of evaluable participants who achieved complete response \[CR\] or partial response \[PR\] according to RECIST criteria version 1.0. * CR reflected the disappearance of all tumor lesions (with no new tumors) * PR reflected a pre-defined reduction in tumor burden Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.
- time origin
- From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0003
- source section id
- NCT00561470-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Adverse Events (AE)
- endpoint definition
- All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.
- time origin
- From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0004
- source section id
- NCT00561470-om-0004
- source outcome index
- 4
- endpoint
- Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay
- endpoint definition
- Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.
- time origin
- Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Placebo/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 614
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Aflibercept/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 612
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Placebo/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 614
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Aflibercept/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 612
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Placebo/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 530
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Aflibercept/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 531
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Placebo/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 605
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Aflibercept/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
- analyzed count
- 611
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Placebo/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- analyzed count
- 526
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Aflibercept/FOLFIRI
- regimen
- Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- analyzed count
- 521
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00561470-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- harm key
- EG000
- source section id
- NCT00561470-ae
- event group key
- EG000
- event group label
- Placebo/FOLFIRI
- serious affected
- 198
- serious at risk
- 605
- other affected
- 575
- other at risk
- 605
- frequency threshold
- 5
- collection period
- From treatment initiation to 7 February, 2011
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00561470
- harm key
- EG001
- source section id
- NCT00561470-ae
- event group key
- EG001
- event group label
- Aflibercept/FOLFIRI
- serious affected
- 294
- serious at risk
- 611
- other affected
- 599
- other at risk
- 611
- frequency threshold
- 5
- collection period
- From treatment initiation to 7 February, 2011
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice