Trial · NCT00574275
Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
NCT00574275, Phase 3, Terminated, Sanofi; results first posted 2012-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer. Trials, record NCT00574275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00574275
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
- NCT number
- NCT00574275
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 546 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Pancreatic Neoplasm
- Interventions
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), Placebo, Gemcitabine
- First posted
- 2007-12-17
- Last updated
- 2016-06-07
- Other registries' IDs
- eudract:2007-003476-19
- Results first posted
- 2012-09-25
- Limitations and caveats
As the study was terminated due to futility, some changes were made to the planned analyses, and the analyses for the following outcome measures were not performed:~* Objective Response Rate (ORR)~* Clinical Benefit
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the first randomization until the end of study data cutoff date (approximately 2 years) | OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009). OS time was estimated from Kaplan-Meier Plots. |
| Secondary | Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria | From the first randomization until the end of study data cutoff date (approximately 2 years) | PFS was the time interval from the date of registration to the date of progression, or death from any cause if it occurs before tumor progression is documented. Tumor progression was assessed using RECIST criteria, by which progression was a pre-defined increase in the size of existing tumors or appearance of one or more new tumors. If a participant did not progress or die, the progression was censored to the date of the last valid tumor assessment or data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. |
| Secondary | Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria | From the first randomization until the end of the study data cutoff date (approximately 2 years) | Objective response (OR) included complete response \[CR\] and partial response \[PR\]. OR was to be assessed by the Investigators according to RECIST criteria, and confirmed by repeating tumor imaging at least 4 weeks after the first radiological documentation of response. CR would reflect the disappearance of all tumor lesions and PR would reflect a defined reduction of tumor burden. However, OR analysis was not performed, as the study was terminated due to futility. |
| Secondary | Clinical Benefit | From the first randomization until the end of the study data cutoff date (approximately 2 years) | Clinical benefit was to be assessed in all participants by time to symptom worsening (TTSW), evaluated from the time of randomization to symptom worsening, as well as by improvement in tumor related symptoms. However, this analysis was not performed, as the study was terminated due to futility. |
| Secondary | Safety-Number of Participants With Adverse Events (AE) | up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized. | All AEs regardless of seriousness or relationship to study treatment, spanning from the signature of informed consent until 30 days after the last administration of study treatment, were recorded. 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. |
| Secondary | Number of Participants With Anti-drug Antibodies | Up to 90 days post last dose of study drug | Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. The validated lower limit of detection (LLOD) for the assay was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the first randomization until the end of study data cutoff date (approximately 2 years) | Intent-to-treat (ITT) population, which included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria | From the first randomization until the end of study data cutoff date (approximately 2 years) | Intent-to-treat (ITT) population, which included all randomized participants. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria | From the first randomization until the end of the study data cutoff date (approximately 2 years) | Since the study was terminated due to futility, this analysis was not performed. | ||
| SECONDARY | Clinical Benefit | From the first randomization until the end of the study data cutoff date (approximately 2 years) | Since the study was terminated due to futility, analysis for this endpoint was not performed. | ||
| SECONDARY | Safety-Number of Participants With Adverse Events (AE) | up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized. | The safety population included all randomized participants who were administered at least 1 dose of study medications (placebo, aflibercept, or gemcitabine). For safety analyses, participants were analyzed according to the treatment received. | participants | NUMBER |
| SECONDARY | Number of Participants With Anti-drug Antibodies | Up to 90 days post last dose of study drug | Safety population with samples available for analysis | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Placebo and Gemcitabine | 7.75 | 95% Confidence Interval 6.768 to 8.575 | months | |
| Overall Survival (OS) | Aflibercept and Gemcitabine | 6.54 | 95% Confidence Interval 5.552 to 7.852 | months | |
| Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria | Placebo and Gemcitabine | 3.71 | 95% Confidence Interval 3.515 to 4.567 | months | |
| Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria | Aflibercept and Gemcitabine | 3.71 | 95% Confidence Interval 3.450 to 4.468 | months | |
| Safety-Number of Participants With Adverse Events (AE) | Placebo and Gemcitabine | Treatment Emergent Adverse Event (TEAE) | 257 | participants | |
| Safety-Number of Participants With Adverse Events (AE) | Aflibercept and Gemcitabine | Treatment Emergent Adverse Event (TEAE) | 266 | participants | |
| Safety-Number of Participants With Adverse Events (AE) | Placebo and Gemcitabine | Treatment Emergent Serious Adverse Event | 122 | participants | |
| Safety-Number of Participants With Adverse Events (AE) | Aflibercept and Gemcitabine | Treatment Emergent Serious Adverse Event | 148 | participants | |
| Safety-Number of Participants With Adverse Events (AE) | Placebo and Gemcitabine | TEAE leading to death | 43 | participants | |
| Safety-Number of Participants With Adverse Events (AE) | Aflibercept and Gemcitabine | TEAE leading to death | 55 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo and Gemcitabine | 275 | |
| Overall Study | STARTED | Aflibercept and Gemcitabine | 271 | |
| Overall Study | TREATED | Placebo and Gemcitabine | 273 | |
| Overall Study | TREATED | Aflibercept and Gemcitabine | 268 | |
| Overall Study | SAFETY POPULATION | Placebo and Gemcitabine | 271 | |
| Overall Study | SAFETY POPULATION | Aflibercept and Gemcitabine | 270 | |
| Overall Study | COMPLETED | Placebo and Gemcitabine | 0 | |
| Overall Study | COMPLETED | Aflibercept and Gemcitabine | 0 | |
| Overall Study | NOT COMPLETED | Placebo and Gemcitabine | 275 | |
| Overall Study | NOT COMPLETED | Aflibercept and Gemcitabine | 271 |
Source ClinicalTrials.gov
Adverse events414
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 | Urinary tract infection | Infections and infestations | Placebo and Gemcitabine | 17 | 271 | |
| other | Urinary tract infection | Infections and infestations | Aflibercept and Gemcitabine | 16 | 270 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and Gemcitabine | 71 | 271 | |
| other | Neutropenia | Blood and lymphatic system disorders | Aflibercept and Gemcitabine | 85 | 270 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo and Gemcitabine | 17 | 271 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Aflibercept and Gemcitabine | 47 | 270 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo and Gemcitabine | 72 | 271 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Aflibercept and Gemcitabine | 78 | 270 | |
| other | Insomnia | Psychiatric disorders | Placebo and Gemcitabine | 18 | 271 | |
| other | Insomnia | Psychiatric disorders | Aflibercept and Gemcitabine | 28 | 270 |
1 to 10 of 414Source ClinicalTrials.gov
See all 414 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo and Gemcitabine | ||
| Total, all-cause mortality | Aflibercept and Gemcitabine | ||
| Total, other adverse events | Placebo and Gemcitabine | 239 | 271 |
| Total, other adverse events | Aflibercept and Gemcitabine | 249 | 270 |
| Total, serious adverse events | Placebo and Gemcitabine | 122 | 271 |
| Total, serious adverse events | Aflibercept and Gemcitabine | 148 | 270 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23642329 | RESULT |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo and Gemcitabine vs Aflibercept and Gemcitabine: Number of Participants With Anti-drug Antibodies | Trial comparisons |
| Placebo and Gemcitabine vs Aflibercept and Gemcitabine: serious adverse events | Trial comparisons |
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/NCT00574275
GET https://conductscience.org/api/trials/v1/NCT00574275/events?page=2