Trial · NCT00284141
Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma
NCT00284141, Phase 2, Completed, Sanofi; results first posted 2012-12-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma. Trials, record NCT00284141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00284141
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma
- NCT number
- NCT00284141
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 98 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Pulmonary Diseases, Neoplasms, Lung
- Interventions
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
- First posted
- 2006-01-31
- Last updated
- 2012-12-10
- Results first posted
- 2012-12-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). | up to 2.5 years from initial treatment | OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions). Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response. |
| Primary | Confirmed Objective Response Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Investigator. | up to 2.5 years from initial treatment | OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions). Assessments were made by the Investigator, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response. |
| Secondary | Duration of Response (DR) | up to 2.5 years from initial treatment | DR was the time interval from the first complete response (CR) or partial response (PR) to the date of tumor progression or death from any cause, whichever was earlier. The duration of response was calculated only for those participants who achieved CR or PR. |
| Secondary | Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC) | up to 2.5 years from initial treatment | PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. |
| Secondary | Progression-free Survival (PFS) Time Assessed by the Investigator | up to 2.5 years from initial treatment | PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors. |
| Secondary | Overall Survival (OS) | up to 2.5 years from initial treatment | OS was the time interval between registration to the date of death from any cause. The median time for OS was estimated from Kaplan-Meier Plots. A participant was to be censored for the OS analysis if the participant was alive by the study cut-off date. The censoring date was either the date that the participant was last known to be alive or the date of study cut-off, whichever came earlier. |
| Secondary | Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale | Baseline to 2.5 years | HRQL was assessed with the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, which was completed by the participants on Day 1 of Cycle 1 only (for baseline value), then on Day 14 of each even-numbered cycle to evaluate the participants symptoms. The questionnaire scored 7 symptoms: shortness of breath, weight loss, clarity in thinking, coughing, appetite, chest tightness, ease of breathing, on a 0-4 scale. The total FACT-LCS score ranged from 0-28 (where 28 was related to the worst outcome). To calculate a change, the baseline score was subtracted from the score obtained after treatment. A negative value implied an improvement in HRQL. |
| Secondary | Overall Safety - Number of Participants With Adverse Events | up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008) | All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 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. |
| Secondary | Number of Participants With Laboratory Abnormalities | Up to 2.5 years | Participants with abnormal laboratory results for * Liver and renal function (Alkaline phosphatase, Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], Creatinine, Hyperbilirubinemia), * Electrolytes (Hypercalcemia, Hypocalcemia, Hypokalemia, Hypernatremia, Hyponatremia, Hypophosphatemia) * Metabolism (Hypoalbuminemia, Hyperglycemia, Hypoglycemia) * Hematology (Partial thromboplastin time, Anemia, Lymphopenia, Neutropenia, Thrombocytopenia, Leukopenia) |
| Secondary | Peak of Free Aflibercept (VEGF Trap) | Day 1 of the first infusion of Aflibercept (cycle 1) | Plasma free aflibercept levels after the first aflibercept infusion were estimated by a validated direct measured by enzyme-linked immunosorbent assay (ELISA), with a limit of quantification (LOQ) of 15.6 ng/mL. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). | up to 2.5 years from initial treatment | Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power. | Participants | NUMBER |
| SECONDARY | Duration of Response (DR) | up to 2.5 years from initial treatment | No modified RECIST responses, as confirmed by the IRC review, were observed. Only 2 responders were reported by the Investigators. Therefore, the analyses for duration of response was not performed. | ||
| SECONDARY | Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC) | up to 2.5 years from initial treatment | All registered participants. 18 participants were censored. | weeks | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Time Assessed by the Investigator | up to 2.5 years from initial treatment | All registered participants. 17 participants were censored. | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | up to 2.5 years from initial treatment | All registered participants. 38 participants were censored for OS. | months | MEDIAN |
| SECONDARY | Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale | Baseline to 2.5 years | All registered participants with available questionnaires at the timepoint assessed. | score on a scale | MEAN |
| SECONDARY | Overall Safety - Number of Participants With Adverse Events | up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008) | All participants who received at least part of 1 dose of study treatment. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities | Up to 2.5 years | All participants who received at least part of 1 dose of study treatment. | Participants | NUMBER |
| SECONDARY | Peak of Free Aflibercept (VEGF Trap) | Day 1 of the first infusion of Aflibercept (cycle 1) | All participants who received at least part of 1 dose of study treatment and had evaluable blood samples. | micrograms/mL | MEAN |
| SECONDARY | Free and VEGF-bound Trough Aflibercept Concentrations (VEGF Trap) | At the end of each treatment cycle (up to 2.5 years) | All participants who received at least part of 1 dose of study treatment and had evaluable blood samples on Day 1 of Cycle 3 for measurement of VEGF-bound aflibercept. | micrograms/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). | Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST | 0 | Participants | ||
| Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). | Aflibercept 4.0 mg/kg Arm Assessed by RECIST | 0 | Participants | ||
| Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC) | Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST | 11.3 | 95% Confidence Interval 9.3 to 16.1 | weeks | |
| Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC) | Aflibercept 4.0 mg/kg Arm Assessed by RECIST | 11.3 | 95% Confidence Interval 9.3 to 16.1 | weeks | |
| Progression-free Survival (PFS) Time Assessed by the Investigator | Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST | 12.0 | 95% Confidence Interval 10.0 to 16.0 | weeks | |
| Progression-free Survival (PFS) Time Assessed by the Investigator | Aflibercept 4.0 mg/kg Arm Assessed by RECIST | 11.9 | 95% Confidence Interval 9.7 to 14.7 | weeks | |
| Overall Survival (OS) | Aflibercept 4.0 mg/kg | 26.9 | 95% Confidence Interval 21.0 to 49.3 | months | |
| Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale | Aflibercept 4.0 mg/kg | Baseline FACT-LCS Score (N=83) | 19.9 | Standard Deviation 3.9 | score on a scale |
| Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale | Aflibercept 4.0 mg/kg | Change from baseline at Cycle 2 (N=58) | -1.5 | Standard Deviation 3.6 | score on a scale |
| Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale | Aflibercept 4.0 mg/kg | Change from baseline at Cycle 4 (N=41) | -1.9 | Standard Deviation 4.7 | score on a scale |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aflibercept 4.0 mg/kg | 98 | |
| Overall Study | TREATED | Aflibercept 4.0 mg/kg | 96 | |
| Overall Study | ONGOING TREATMENT | Aflibercept 4.0 mg/kg | 2 | |
| Overall Study | COMPLETED | Aflibercept 4.0 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Aflibercept 4.0 mg/kg | 98 |
Source ClinicalTrials.gov
Adverse events99
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 | Abdominal pain | Gastrointestinal disorders | 4 mg/kg | 6 | 96 | |
| other | Constipation | Gastrointestinal disorders | 4 mg/kg | 27 | 96 | |
| other | Diarrhoea | Gastrointestinal disorders | 4 mg/kg | 12 | 96 | |
| other | Dry mouth | Gastrointestinal disorders | 4 mg/kg | 6 | 96 | |
| other | Dysphagia | Gastrointestinal disorders | 4 mg/kg | 6 | 96 | |
| other | Nausea | Gastrointestinal disorders | 4 mg/kg | 23 | 96 | |
| other | Oral pain | Gastrointestinal disorders | 4 mg/kg | 5 | 96 | |
| other | Vomiting | Gastrointestinal disorders | 4 mg/kg | 16 | 96 | |
| other | Asthenia | General disorders | 4 mg/kg | 16 | 96 | |
| other | Chest pain | General disorders | 4 mg/kg | 5 | 96 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 4 mg/kg | ||
| Total, other adverse events | 4 mg/kg | 93 | 96 |
| Total, serious adverse events | 4 mg/kg | 48 | 96 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20593550 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST vs Aflibercept 4.0 mg/kg Arm Assessed by RECIST: Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). |
Source 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/NCT00284141
GET https://conductscience.org/api/trials/v1/NCT00284141/results?page=2