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Last Updated: December 9, 2019

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CLINICAL TRIALS PROFILE FOR ZIV-AFLIBERCEPT

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All Clinical Trials for ziv-aflibercept

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00284141 Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma Completed Regeneron Pharmaceuticals Phase 2 2006-01-01 This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: - To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Secondary objective: - To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population - To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®). 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. In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
NCT00284141 Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma Completed Sanofi Phase 2 2006-01-01 This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: - To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Secondary objective: - To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population - To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®). 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. In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
NCT00320775 Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD Completed Bayer Phase 1 2005-06-01 The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
NCT00320775 Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD Completed Regeneron Pharmaceuticals Phase 1 2005-06-01 The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
NCT00327171 Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer Completed Regeneron Pharmaceuticals Phase 2 2006-05-01 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.
NCT00327171 Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer Completed Sanofi Phase 2 2006-05-01 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.
NCT00327444 Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites Completed Regeneron Pharmaceuticals Phase 2/Phase 3 2006-07-01 This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer. Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ziv-aflibercept

Condition Name

Condition Name for ziv-aflibercept
Intervention Trials
Diabetic Macular Edema 41
Neovascular Age-Related Macular Degeneration 18
Wet Macular Degeneration 15
Metastatic Colorectal Cancer 14
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Condition MeSH

Condition MeSH for ziv-aflibercept
Intervention Trials
Macular Degeneration 82
Macular Edema 75
Edema 52
Wet Macular Degeneration 48
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Clinical Trial Locations for ziv-aflibercept

Trials by Country

Trials by Country for ziv-aflibercept
Location Trials
United States 789
Japan 73
Canada 59
Italy 56
Germany 51
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Trials by US State

Trials by US State for ziv-aflibercept
Location Trials
California 46
Texas 45
New York 32
Pennsylvania 30
North Carolina 28
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Clinical Trial Progress for ziv-aflibercept

Clinical Trial Phase

Clinical Trial Phase for ziv-aflibercept
Clinical Trial Phase Trials
Phase 4 76
Phase 3 45
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for ziv-aflibercept
Clinical Trial Phase Trials
Recruiting 81
Completed 71
Not yet recruiting 46
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Clinical Trial Sponsors for ziv-aflibercept

Sponsor Name

Sponsor Name for ziv-aflibercept
Sponsor Trials
Regeneron Pharmaceuticals 83
Bayer 39
Sanofi 38
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Sponsor Type

Sponsor Type for ziv-aflibercept
Sponsor Trials
Industry 215
Other 215
NIH 18
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