Trial · NCT01571284
Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen
NCT01571284, Phase 3, Completed, Sanofi; results first posted 2018-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen. Trials, record NCT01571284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01571284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen
- NCT number
- NCT01571284
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 781 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Colorectal Cancer Metastatic
- Interventions
- AFLIBERCEPT AVE0005, FOLFIRI
- First posted
- 2012-04-05
- Last updated
- 2018-04-17
- Results first posted
- 2018-02-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs. |
| Primary | Number of Participants With Abnormal Hematological Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Abnormal hematological parameters included: anaemia, thrombocytopenia, leukopenia and neutropenia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4 as per NCI CTCAE (Version 4.03), where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4. |
| Primary | Number of Participants With International Normalized Ratio (INR) | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | The INR is a derived measure of the prothrombin time. The INR is the ratio of a participant's prothrombin time to a normal control sample. Normal range (without anti coagulation therapy): 0.8-1.2; Targeted range (with anti coagulation therapy) 2.0-3.0. |
| Primary | Number of Participants With Abnormal Electrolytes Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Abnormal electrolytes parameters included: hyponatremia, hypernatremia, hypocalcemia, hypercalcemia, hypokalemia, and hyperkalemia. Number of participants with each of these parameters were analyzed by grades ( All Grades and Grades 3-4 as per NCI CTCAE Version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4. |
| Primary | Number of Participants With Abnormal Renal and Liver Function Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Renal and liver function parameters included: creatinine, hyperbilirubinemia, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4. |
| Primary | Creatinine Clearance of Aflibercept Plus FOLFIRI | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance was calculated using the Cockroft-Gault or Modification of Diet in Renal Disease (MDRD). |
| Primary | Number of Participants With Other Abnormal Biochemistry Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Other abnormal biochemistry parameters included: hypoglycemia, hyperglycemia and hypoalbuminemia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE Version 4.03, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4. |
| Primary | Number of Participants With Abnormal Non-Gradable Biochemistry Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Non-gradeable biochemistry parameters included; chloride, urea, total protein, blood urea nitrogen (BUN) and lactate dehydrogenase (LDH). Number of participants with \<lower limit of normal ranges (LLN) and \>upper limit of normal ranges (ULN) for each of these parameters were reported. |
| Primary | Number of Participants With Proteinuria Events | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria were analyzed by grades (Grades 1, 2, 3 ,4) as per NCI CTCAE Version 4.03 where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. |
| Primary | Number of Participants With Proteinuria Grade >=2 | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria grade \>=2 (graded as per NCI CTCAE Version 4.03), where Grade\>=2 represents moderate to life-threatening/disabling event. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Hematological Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. Here, 'Number Analyzed = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With International Normalized Ratio (INR) | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Electrolytes Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Renal and Liver Function Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Creatinine Clearance of Aflibercept Plus FOLFIRI | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. Overall number of participants analyzed = participants evaluable for this outcome measure. | mL/min | MEAN |
| PRIMARY | Number of Participants With Other Abnormal Biochemistry Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. Here, 'Number Analyzed' = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Non-Gradable Biochemistry Parameters | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. Here, 'Number Analyzed = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Proteinuria Events | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Proteinuria Grade >=2 | Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Safety population | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group402
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Any TEAE (All Grades) | 769 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Any TEAEs (Grades 3-4) | 609 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Any serious TEAE | 272 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Any serious related TEAE | 159 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Any TEAE leading to death | 47 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Any TEAE (permanent treatment discontinuation) | 208 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Any TEAE (premature treatment discontinuation) | 104 | Participants | |
| Number of Participants With Abnormal Hematological Parameters | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Anaemia: All Grades | 535 | Participants | |
| Number of Participants With Abnormal Hematological Parameters | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Anaemia: Grades 3-4 | 14 | Participants | |
| Number of Participants With Abnormal Hematological Parameters | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | Thrombocytopenia: All Grades | 293 | Participants |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 781 | |
| Overall Study | Safety Population | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 779 | |
| Overall Study | COMPLETED | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 612 | |
| Overall Study | NOT COMPLETED | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 169 |
Source ClinicalTrials.gov
Adverse events200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 277 | 779 | |
| other | Abdominal Pain | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 150 | 779 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 67 | 779 | |
| other | Constipation | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 148 | 779 | |
| other | Diarrhoea | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 464 | 779 | |
| other | Nausea | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 337 | 779 | |
| other | Proctalgia | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 39 | 779 | |
| other | Stomatitis | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 329 | 779 | |
| other | Vomiting | Gastrointestinal disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 190 | 779 | |
| other | Asthenia | General disorders | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 192 | 779 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 48 | 779 |
| Total, other adverse events | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 744 | 779 |
| Total, serious adverse events | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 272 | 779 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31221542 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01571284
GET https://conductscience.org/api/trials/v1/NCT01571284/results?page=2