Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
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| ClinicalTrials.gov Identifier: NCT00327444 |
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Recruitment Status :
Completed
First Posted : May 18, 2006
Results First Posted : January 1, 2013
Last Update Posted : January 1, 2013
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Conditions |
Ovarian Neoplasms Ascites |
| Interventions |
Drug: aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) Drug: Placebo |
| Enrollment | 58 |
Participant Flow
| Recruitment Details | Fifty-eight (58) participants from a total of 23 sites in 7 countries were enrolled in the study. |
| Pre-assignment Details | 55 were randomized (started population). 3 participants were not randomized but they were treated, and permanently withdrawn from the study due to disease progression (1 participant), fatal disease progression (1 participant) and a treatment emergent adverse event (1 participant). |
| Arm/Group Title | Placebo | Aflibercept |
|---|---|---|
 Arm/Group Description |
Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period. | Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period. |
| Period Title: Double Blind Treatment (DB) Period | ||
| Started | 26 | 29 |
| SAFETY | 25 [1] | 30 [2] |
| Completed | 0 | 0 |
| Not Completed | 26 | 29 |
| Reason Not Completed | ||
| Disease progression | 10 | 13 |
| Adverse Event | 5 | 5 |
| Subject request | 0 | 1 |
| Withdrew DB and continued to OL | 11 | 10 |
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[1]
Excludes one participant from the Placebo arm who received aflibercept in error in the DB period.
[2]
Includes 1 from Placebo who received aflibercept in DB period
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| Period Title: Open Label Treatment (OL) Period | ||
| Started | 11 | 10 |
| ONGOING TREATMENT | 1 | 0 |
| Completed | 0 [1] | 0 [1] |
| Not Completed | 11 | 10 |
| Reason Not Completed | ||
| Disease progression | 8 | 7 |
| Adverse Event | 2 | 2 |
| Worsening dyspnea | 0 | 1 |
| Ongoing Treatment | 1 | 0 |
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[1]
All participants were treated till they met treatment discontinuation criteria
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Baseline Characteristics
| Arm/Group Title | Placebo | Aflibercept | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period. | Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 26 | 29 | 55 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 26 participants | 29 participants | 55 participants |
| < 35 years | 0 | 1 | 1 | |
| >=35 to <45 years | 5 | 1 | 6 | |
| >=45 to <55 years | 10 | 7 | 17 | |
| >=55 to <65 years | 4 | 11 | 15 | |
| >=65 to <75 years | 6 | 7 | 13 | |
| >=75 years | 1 | 2 | 3 | |
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[1]
Measure Description: Baseline characteristics are reported for the randomized population
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 26 participants | 29 participants | 55 participants | |
| Female |
26 100.0%
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29 100.0%
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55 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 26 participants | 29 participants | 55 participants |
| Caucasian | 19 | 22 | 41 | |
| Black | 1 | 0 | 1 | |
| Asian, Oriental | 6 | 7 | 13 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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 (20 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).
Results Point of Contact
| Name/Title: | Trial Transparency Team |
| Organization: | Sanofi |
| EMail: | Contact-Us@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00327444 |
| Other Study ID Numbers: |
EFC6125 EudraCT : 2005-005026-31 AVE0005A /3001 |
| First Submitted: | May 16, 2006 |
| First Posted: | May 18, 2006 |
| Results First Submitted: | August 17, 2012 |
| Results First Posted: | January 1, 2013 |
| Last Update Posted: | January 1, 2013 |