A Multicenter, Open-Label, Single-Arm Study of Intravenous AVE0005 VEGF Trap Administered Every 2 Weeks in Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites - ND

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2006-000604-16-IT
• Date of registration: 27/10/2006
• Prospective Registration: No
• Primary sponsor: Sanofi-Synthelabo Recherche, a subsidiary of sanofi-aventis group
• Public title: A Multicenter, Open-Label, Single-Arm Study of Intravenous AVE0005 VEGF Trap Administered Every 2 Weeks in Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites - ND
• Scientific title: A Multicenter, Open-Label, Single-Arm Study of Intravenous AVE0005 VEGF Trap Administered Every 2 Weeks in Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites - ND
• Date of first enrolment: 03/08/2006
• Target sample size: 15
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000604-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Italy, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures and agrees to participate in the study by providing written informed consent prior to any study-related requirements. 2. Patient is female or equal to 18 years of age. 3. Patient has symptomatic malignant ascites resulting from advanced ovarian epithelial cancer including fallopian tube and primary peritoneal adenocarcinoma that has required at least 3 previous therapeutic paracenteses at a frequency of 1-4 paracenteses per month for management. 4. Platinum-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. 5. Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. 6. Patient underwent Day 1 paracentesis for symptoms consistent with abdominal discomfort, bloating, or pain with or equal to 1 liter of ascitic fluid removed. 7. Patient has an Eastern Cooperative Oncology Group ECOG performance status or equal to 2. 8. Patient is postmenopausal, surgically sterile, or using effective contraception. 9. Patient has adequate organ and bone marrow function as evidenced by hemoglobin or equal 8.0 g/dL; absolute neutrophil count or equal to 1.0 x 10 9 /L platelet count or equal to 75 x 10 9 /L creatinine or equal to 1.5 x ULN, and either proteinuria or equal to 500 mg/24 hours or urine protein creatinine ratio UPCR or equal to 1; AST/SGOT, ALT/SGPT, and total bilirubin or equal to 2.5 x ULN; international normalized ratio INR within normal limits or or equal to 1.5 x ULN if on prophylactic anticoagulation and activated partial thromboplastin time aPTT within normal limits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patient has pseudomyxoma peritonei or peritoneal mesothelioma. 2. Patient has radiographic evidence of intestinal obstruction e.g., dilated loops of bowel accompanied by air-fluid levels requiring surgical intervention or gastrointestinal perforation e.g., presence of extraluminal gas requiring surgical intervention. 3. Patient has ascites associated with a non-malignant condition, including but not limited to ascites associated with mechanical obstruction, congestive heart failure, constrictive pericarditis, portal hypertension, hypoproteinemia of hepatic failure or nephrotic syndrome often associated with serum to ascites albumin gradient 1.1, i.e. transudative ascites . 4. Patient has a peritoneovenous or other type of shunt that was placed for the management of ascites. 5. Anticipation of need for a major surgical procedure or radiation therapy during the study. 6. Likelihood of requiring treatment during the study period with drugs or devices not permitted by the clinical trial protocol. 7. Patient has had any of the following conditions within 6 months prior to study entry myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, peptic ulcer disease, erosive esophagitis or gastritis, hepatic cirrhosis, portal venous obstruction, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, deep vein thrombosis, or other thromboembolic event. 8. Patient has uncontrolled hypertension with or without antihypertensive drug treatment , defined as blood pressure 150/100 mm Hg or systolic blood pressure 180 mm Hg on at least 2 repeated determinations on separate days within 3 months prior to study entry. 9. Patient has received tumor-directed immunologic therapy, targeted therapy, radiation therapy, surgery, chemotherapy, or an investigational agent including FDA approved drugs for a non-FDA approved indication within 3 weeks prior to study entry. For major surgery, mitomycin or nitrosoureas, there must be a 6-week treatment-free interval. 10. Patient has a known history of hypersensitivity to any Trap agent or recombinant proteins. 11. Patient has been previously treated with AVE0005 VEGF Trap , bevacizumab, or other inhibitor of VEGF or VEGFR. 12. Patient has a serious, unresolved complication of malignant disease including, but not limited to, untreated superior vena cava syndrome, spinal cord compression, or refractory hypercalcemia of malignancy. 13. Patient has previously known brain metastases, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. 14. Patient has known, clinically significant, active infection or bleeding, or underlying bleeding disorder. 15. Patient has a history of any condition social or medical that, in the opinion of the investigator, might confound the results of the study, or pose additional, unacceptable risk to the patient. 16. Patient is pregnant, breastfeeding, planning to become pregnant or unwilling to use effective contraception. 17. Patient is mentally or legally incapacitated unable to understand the nature, scope and possible consequences of the study at the time of the study or has been 1 year prior to study entry a user of illicit drugs or abuser of alcohol. 18. Patient is unlikely to either comply with the protocol e.g., uncooperative attitude, inability to return fo

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Advanced ovarian cancer patients with recurrent symptomatic malignant ascites
MedDRA version: 8.1 Level: LLT Classification code 10025538 Term: Malignant ascites

Intervention(s)

Product Name: VEGF-TRAP
Product Code: AVE0005
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 862111-32-8
Current Sponsor code: AVE0005
Other descriptive name: VEGF-TRAP
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint will be repeat paracentesis response RPR defined as at least a twofold increase in TRP as compared to the average of the 2 intervals between the 3 most recent paracenteses prior to study registration. TRP will be defined as the number of days between the date of registration and the date of the first post-registration paracentesis. For this endpoint, each patient will be followed for 6 months or until study withdrawal.

Secondary Objective: Estimate the general safety and tolerability of AVE0005 VEGF Trap in advanced ovarian cancer patients with recurrent symptomatic malignant ascites. Estimate the effect of AVE0005 VEGF Trap treatment on time to repeat paracentesis TRP and 60-day frequency of paracentesis FOP . Estimates the effect of AVE0005 VEGF Trap treatment on progression-free survival PFS , and overall survival OS in advanced ovarian cancer patients with recurrent symptomatic malignant ascites. Determine if human anti-AVE0005 VEGF Trap antibodies develop in advanced ovarian cancer patients with recurrent symptomatic malignant ascites treated with AVE0005 VEGF Trap

Main Objective: Estimate the repeat paracentesis response rate RPRR in advanced ovarian cancer patients with recurrent symptomatic malignant ascites

Secondary ID(s)

2006-000604-16-SE

ARD 6722