- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396591
AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
A Multicenter, Open-label, Single-arm Study of the Efficacy and Safety of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites.
The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study consisted of:
- A 30-day screening phase prior to Day 1
- Day 1 registration and pre-treatment paracentesis
- Aflibercept administration within 1-day of registration
- Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
- A 60-day post-treatment follow-up phase
During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation:
- Participant (or legal representative) chose to withdraw from treatment
- The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being
- Participant had intercurrent illness that prevented further administration of investigational product (IP)
- Participant had more than 2 IP dose reductions
- Participant had unacceptable adverse events (AEs)
- Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina
- Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Milano, Italy
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Bromma, Sweden
- Sanofi-Aventis Administrative Office
-
-
-
-
New Jersey
-
Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Participants that met the following criteria were eligible.
Inclusion Criteria:
- Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management.
- Platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
- Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
Exclusion Criteria:
- Peritoneovenous or other type of shunt that was placed for the management of ascites
- Prior treatment with a VEGF or VEGF receptor inhibitor
- Uncontrolled hypertension
The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aflibercept
Participants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
|
4.0 mg/kg administered intravenously (IV) once every 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Repeat Paracentesis Response (RPR)
Time Frame: up to 2 years post-registration
|
RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis). Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants * 100. |
up to 2 years post-registration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Repeat Paracentesis (TRP)
Time Frame: up to 6 months from registration
|
TRP is the number of days between the date of registration and the date of the first postregistration paracentesis.
Median TRP was estimated from Kaplan-Meier curves.
For participants who did not undergo a postregistration paracentesis while on study, TRP was censored at the end of the treatment period (last dose + 1 cycle), at the last visit known without repeat paracentesis, at 6 months postregistration, or at death, whichever was earlier.
|
up to 6 months from registration
|
60-day Frequency of Paracentesis (FOP)
Time Frame: up to 60 days post-registration
|
FOP was the total number of paracenteses performed within the first 60 days postregistration.
For participants who had withdrawn after registration but prior to the 60-day cutoff date, the withdrawal would have been regarded as a paracentesis event and the 60-day FOP normalized and calculated as the nearest integer of the value corresponding to 60 × number of paracenteses / x, where x represents the number of days on study.
|
up to 60 days post-registration
|
Progression-free Survival (PFS) Time
Time Frame: up to 6 months post-registration
|
According to the Response Evaluation Criteria in Solid Tumors [RECIST], 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. PFS time was interval from the date of registration to the date of tumor progression or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots. If participants were alive and progression-free at 6 months postregistration, they were censored for PFS. |
up to 6 months post-registration
|
Overall Survival (OS) Time
Time Frame: up to 6 months post-registration
|
OS time was the time interval between the date of registration to the date of death from any cause.
Median OS was estimated from Kaplan-Meier curves.
Participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.
|
up to 6 months post-registration
|
Number of Participants With a Positive Anti-drug Antibody Response
Time Frame: up to 60 days after the last dose of treatment
|
Anti-drug antibodies in participant's serum were measured using 2 different methods
Participants with detectable anti-drug antibodies by either method were considered to have a positive anti-drug antibody response. |
up to 60 days after the last dose of treatment
|
Safety - Number of Participants With Adverse Events (AE)
Time Frame: up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized
|
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.
|
up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Ascites
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Aflibercept
Other Study ID Numbers
- ARD6772
- EUDRACT: 2006-000604-16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Neoplasms
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Ovarian Neoplasm | Ovarian Clear Cell Tumor | Adnexal Mass | Ovarian Endometrioid Tumor | Ovarian Serous Tumor | Borderline Ovarian Epithelial TumorUnited States
-
Maastricht University Medical CenterVieCuri Medical Centre; Orbis Medical Centre; St.Jans Gasthuis Weert; Laurentius...TerminatedOvarian Cancer | Ovarian Carcinoma | Ovarian Cyst | Ovarian MassNetherlands
-
Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
-
GlaxoSmithKlineCompletedNeoplasms, OvarianUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Seoul National University HospitalSamsung Medical Center; Takeda; Asan Medical Center; Yonsei UniversityNot yet recruitingOvarian Cancer | Epithelial Ovarian Cancer | Ovarian Cancer Stage IV | Ovarian Cancer Stage III
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
Clinical Trials on Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
-
SanofiRegeneron PharmaceuticalsCompletedOvarian Neoplasms | AscitesUnited States, Canada, Spain, India, Belgium, Austria, Hungary, Israel, United Kingdom
-
SanofiRegeneron PharmaceuticalsCompletedNeoplasms | Cancer of the OvaryUnited States, France, Canada, Australia, Germany, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland
-
SanofiRegeneron PharmaceuticalsCompletedNeoplasms, Lung | Pulmonary DiseasesUnited States, France, Canada
-
National Cancer Institute (NCI)CompletedPancreatic Neuroendocrine Carcinoma | Multiple Endocrine Neoplasia Type 1United States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Ovarian Carcinoma | Pancreatic Neuroendocrine Tumor | Unresectable Solid Neoplasm | Fibrolamellar CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedMetastatic Breast Cancer | Stage IV Breast Cancer | Recurrent Breast CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerCanada
-
National Cancer Institute (NCI)CompletedFallopian Tube Cancer | Uterine Carcinosarcoma | Stage IV Ovarian Epithelial Cancer | Ovarian Sarcoma | Recurrent Uterine Sarcoma | Stage III Uterine Sarcoma | Stage IV Uterine Sarcoma | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial Cancer | Ovarian Carcinosarcoma | Female Reproductive... and other conditionsUnited States, Canada
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedRecurrent Endometrial CarcinomaUnited States