E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Compare the effect of AVE0005 (VEGF Trap) to placebo treatment on time to repeat paracentesis (TRP) in advanced ovarian cancer patients with recurrent symptomatic malignant ascites. |
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E.2.2 | Secondary objectives of the trial |
•Evaluate the general safety and tolerability of AVE0005 (VEGF Trap) in advanced ovarian cancer patients with recurrent symptomatic malignant ascites. •Compare the effect of AVE0005 (VEGF Trap) to placebo treatment on ascites impact measure (AIM) and 60-day frequency of paracentesis (FOP) 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). •Establish the psychometric properties, including construct validity, reliability, and responsiveness, of the Ascites Impact Measure (AIM) questionnaire (English version), and confirm the face and content validity and the measurement properties of the non-English versions of the AIM questionnaire in advanced ovarian cancer patients with recurrent symptomatic malignant ascites. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patient has symptomatic, malignant ascites (ICD-10 CM code C78.6) resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that has required at least 2 previous therapeutic paracenteses at a frequency of 1-4 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. •Patient underwent Day 1 paracentesis for symptoms consistent with abdominal discomfort, bloating, or pain with ≥1 liter of ascitic fluid removed. •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2. |
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E.4 | Principal exclusion criteria |
•Patient has pseudomyxoma peritonei or peritoneal mesothelioma. •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 •Patient has ascites associated with transudative ascites (often associated with serum to ascites albumin gradient >1.1), including but not limited to ascites associated with mechanical obstruction, congestive heart failure, constrictive pericarditis, portal hypertension, hypoproteinemia of hepatic failure or nephrotic syndrome. •Patient has a peritoneovenous or other type of shunt that was placed for the management of ascites. •Patient has been previously treated with AVE0005 (VEGF Trap), bevacizumab, or other inhibitor of VEGF or VEGFR. |
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E.5 End points |
E.5.1 | Primary end point(s) |
TRP (time to repeat paracentesis) defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis. For this endpoint, each patient will be followed for 6 months, until study withdrawal, or until the first post-randomization paracentesis, whichever is earlier. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Determination of the immunogenicity of IV AVE0005 & psychometric validation of the AIM questionnaire |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
After 60 days post-randomization, patients could receive open-label AVE0005 in certain conditions |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |