E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with platinum-resistant and topotecan- and/or liposomal doxorubicin-resistant advanced ovarian cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061328 |
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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 |
To compare the objective response rate ORR of AVE0005 VEGF Trap 4.0 mg/kg and 2.0 mg/kg IV every 2 weeks with historical control in patients with advanced ovarian epithelial including fallopian tube and primary peritoneal adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin. |
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E.2.2 | Secondary objectives of the trial |
To assess clinical benefit response CBR , duration of response DR , tumor marker CA-125 response rate TMRR , time to tumor progression TTP , time to tumor marker CA-125 progression TTMP , progression-free survival PFS , and overall survival OS To evaluate the safety profile of IV AVE0005 VEGF Trap To determine the pharmacokinetics, including population pharmacokinetics, of IV AVE0005 VEGF Trap To determine the immunogenicity of IV AVE0005 VEGF Trap To explore potential biological and pharmacogenomic markers of AVE0005 VEGF Trap activity To assess health-related quality of life HRQL / |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Histologically-confirmed ovarian epithelial including fallopian tube and primary peritoneal adenocarcinoma. Prior treatment with at least 2 treatment regimens in the advanced disease treatment setting. 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. Evidence of at least one unidimensionally measurable tumor lesion by CT or MRI scan according to Response Evaluation Criteria in Solid Tumors RECIST that has not been treated with surgery or radiation therapy |
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E.4 | Principal exclusion criteria |
Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri. Prior treatment with a VEGF or VEGF receptor inhibitor More than 3 chemotherapy regimens in the advanced disease treatment setting Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks 6 weeks for nitrosoureas, mitomycin C, immunotherapy, or cytokine therapy of study enrollment. Uncontrolled hypertension, defined as blood pressure 150/100 mm Hg NCI CTCAE v.3.0 grade 8805;2 , or systolic blood pressure 180 mm Hg if diastolic blood pressure 90 mm Hg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment |
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E.5 End points |
E.5.1 | Primary end point(s) |
To confirme objective response according to RECIST criteria. Confirmation of objective responses will be confirmed by repeat tumor imaging 4-6 weeks later. All imaging studies will be assessed by an independent third-party core imaging laboratory. The data cutoff date for the final analysis of the primary efficacy endpoint will be defined as the earlier of the date 6 months after randomization of the last evaluable patient and the date when response status can be determined for all evaluable patients |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 |
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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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |