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| ID | Type | Description | Link |
|---|---|---|---|
| AVE0005 |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept.
The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin.
The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life.
This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.
The study included:
Withdrawal criteria that led to treatment discontinuation were:
After discontinuing treatment, participants remained on the study until the last post-treatment visit or until recovery of drug related toxicities, whichever was later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept 2.0 mg/kg | Experimental | Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept. |
|
| Aflibercept 4.0 mg/kg | Experimental | Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | Drug | Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks. Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort | OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population | OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC | CBR was defined as having a Stable disease (SD) for >= 6 months or a confirmed OR (PR or CR). Based on RECIST:
|
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Participants who met the following criteria were eligible for the study.
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24127346 | Result | Tew WP, Colombo N, Ray-Coquard I, Del Campo JM, Oza A, Pereira D, Mammoliti S, Matei D, Scambia G, Tonkin K, Shun Z, Sternas L, Spriggs DR. Intravenous aflibercept in patients with platinum-resistant, advanced ovarian cancer: results of a randomized, double-blind, phase 2, parallel-arm study. Cancer. 2014 Feb 1;120(3):335-43. doi: 10.1002/cncr.28406. Epub 2013 Oct 11. | |
| 37185961 |
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218 participants were randomized in this study. Three participants in the 2 mg/kg treatment group did not receive any study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept 2.0 mg/kg | Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks |
| FG001 | Aflibercept 4.0 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | Drug | Aflibercept 2.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks. Aflibercept could be reduced by 1 dose level (to 1.0 mg/kg) or 2 dose levels (to 0.5 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment. |
|
| From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC) | DR was defined as the time interval from the first documentation of CR or PR to the date of tumor progression (or disease progression) as determined by RECIST, or death from any cause, whichever was earlier. Based on RECIST, progressive disease was at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new target or non-target lesions, or the unequivocal progression of existing non-target lesions. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition | TMRR was the proportion of evaluable participants achieving a cancer antigen -125 (CA-125) response based on GCIG definition. A response to CA-125 occurred if after two elevated levels before therapy there was at least a 50% decrease in a post-treatment serum sample, which was confirmed by an independent sample collected 21 days or later that was =< 110% of the post-treatment serum sample. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC | TTP was defined as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST. TTP was estimated from Kaplan-Meier curves. For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Time to Tumor Marker (CA-125) Progression (TTMP) | TTMP was the time interval from the date of randomization to the date of tumor marker progression as was defined by GCIG for the evaluable participants. TTMP was estimated using Kaplan-Meier curves. For a participant who did not reach tumor marker progression (TMP) during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC. | PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. The number of participants with tumor/disease progression are reported. Participants who did not reach tumor progression during study, or had no valid post-baseline tumor burden assessment due to early termination, were censored in the PFS analysis. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Progression-free Survival (PFS) Time Based on Analysis by the IRC | PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. PFS was estimated using Kaplan-Meier curves. For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Overall Survival (OS) Time | OS was the time interval between randomization and the date of death from any cause. OS was estimated using Kaplan-Meier curves A participant was censored for the OS analysis if the participant were alive during the study. The censoring date was either at the date that the participant was last known to be alive or the date of study cut-off, whichever was earlier. | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| Overall Safety - Number of Participants With Adverse Events (AE) | 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. | up to 30+/-5 days after treatment discontinuation, or up to recovery or stabilization of a followed-up adverse event |
| Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire | The FACT-O questionnaire consists of 38 scored questions (scored from 0-4) that address physical well-being, social/family well-being, emotional well-being, functional well-being and some additional concerns which relate specifically to ovarian cancer symptoms. For each question, higher scores reflect a better quality of life. The total FACT-O score ranges from 0-152, with 152 indicating the best outcome. | On Day 1 of Cycle 1 (baseline) , and after Day 14 of Cycle 2 |
| Macquarie Park |
| Australia |
| Sanofi-Aventis Administrative Office | Laval | Canada |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| Sanofi-Aventis Administrative Office | Geneva | Switzerland |
| Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept 2.0 mg/kg | Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks |
| BG001 | Aflibercept 4.0 mg/kg | Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort | OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later. | Simon's cohort: The first 67 evaluable participants, based on Simon's two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls. | Posted | Number | participants | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC | CBR was defined as having a Stable disease (SD) for >= 6 months or a confirmed OR (PR or CR). Based on RECIST:
| Simon's cohort: The first 67 evaluable participants, based on Simon's two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls. | Posted | Number | participants | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC) | DR was defined as the time interval from the first documentation of CR or PR to the date of tumor progression (or disease progression) as determined by RECIST, or death from any cause, whichever was earlier. Based on RECIST, progressive disease was at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new target or non-target lesions, or the unequivocal progression of existing non-target lesions. | Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept. | Posted | Mean | Standard Deviation | days | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition | TMRR was the proportion of evaluable participants achieving a cancer antigen -125 (CA-125) response based on GCIG definition. A response to CA-125 occurred if after two elevated levels before therapy there was at least a 50% decrease in a post-treatment serum sample, which was confirmed by an independent sample collected 21 days or later that was =< 110% of the post-treatment serum sample. | Randomized participants who received at least part of one dose of aflibercept, had a baseline tumor assessment, had a valid CA-125 assessment (requiring at least two pretreatment sample and 2 post-treatment samples), did not receive mouse antibodies and had no medical or surgical interference with their peritoneum or pleura in the previous 28 days. | Posted | Mean | 95% Confidence Interval | percentage of participants | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC | TTP was defined as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST. TTP was estimated from Kaplan-Meier curves. For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization. | Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept. | Posted | Median | 95% Confidence Interval | weeks | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) | Tumor Progression Events | Participants |
| ||||||||||||||||||||||||||||
| Secondary | Time to Tumor Marker (CA-125) Progression (TTMP) | TTMP was the time interval from the date of randomization to the date of tumor marker progression as was defined by GCIG for the evaluable participants. TTMP was estimated using Kaplan-Meier curves. For a participant who did not reach tumor marker progression (TMP) during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization. | Participants with a valid assessment of CA-125 (requiring at least one pretreatment sample and 2 post-treatment samples). | Posted | Median | 95% Confidence Interval | weeks | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) | Tumor Marker Progression events | Participants |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC. | PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. The number of participants with tumor/disease progression are reported. Participants who did not reach tumor progression during study, or had no valid post-baseline tumor burden assessment due to early termination, were censored in the PFS analysis. | Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept. | Posted | Number | participants | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Time Based on Analysis by the IRC | PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. PFS was estimated using Kaplan-Meier curves. For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization. | Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept. | Posted | Median | 95% Confidence Interval | weeks | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) | PFS Events | Participants |
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Time | OS was the time interval between randomization and the date of death from any cause. OS was estimated using Kaplan-Meier curves A participant was censored for the OS analysis if the participant were alive during the study. The censoring date was either at the date that the participant was last known to be alive or the date of study cut-off, whichever was earlier. | Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept. | Posted | Median | 95% Confidence Interval | weeks | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) | Events (Death) | Participants |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population | OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later. | Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept. | Posted | Number | participants | From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Safety - Number of Participants With Adverse Events (AE) | 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. | Safety population: All randomized participants who received at least part of one dose of study treatment. | Posted | Number | participants | up to 30+/-5 days after treatment discontinuation, or up to recovery or stabilization of a followed-up adverse event |
|
| ||||||||||||||||||||||||||||||
| Secondary | Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire | The FACT-O questionnaire consists of 38 scored questions (scored from 0-4) that address physical well-being, social/family well-being, emotional well-being, functional well-being and some additional concerns which relate specifically to ovarian cancer symptoms. For each question, higher scores reflect a better quality of life. The total FACT-O score ranges from 0-152, with 152 indicating the best outcome. | All randomized participants who had evaluable FACT-O questionnaires. | Posted | Mean | Standard Deviation | score on a scale | On Day 1 of Cycle 1 (baseline) , and after Day 14 of Cycle 2 |
|
|
From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept 2.0 mg/kg | Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks | 51 | 106 | 105 | 106 | ||
| EG001 | Aflibercept 4.0 mg/kg | Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks | 56 | 109 | 106 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hepatitis a | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Narcotic intoxication | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac myxoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Metastases to small intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
The investigator shall have the right to independently publish study results from his site after a multicenter publication, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication derived from the study, for review and comment at least 45 days in advance of any submission, and delay publication till the approval of the publication is given in writing by the Sponsor (not to exceed ninety days).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-Us@sanofi.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >=45 to <55 years |
|
| >=55 to <65 years |
|
| >=65 to <75 years |
|
| >=75 years |
|
| Male |
|
| Black |
|
| Asian, Oriental |
|
| Unknown or Not Reported |
|
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| Participants |
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| Participants |
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|---|
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| Participants |
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| Tumor Marker Progression events |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Events (Death) |
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| Participants |
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