E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066697 |
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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 determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS). |
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E.2.2 | Secondary objectives of the trial |
To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival (OS). (The complete list of sec. objectives is listed in the protocol and synopsis). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female of age 18 years or older • Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer - Subjects with pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, carcinosarcoma, or neuroendocrine histology are excluded - Subjects with borderline ovarian cancer, ie, subjects with low malignant potential tumors, are excluded • Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer • Radiographically evaluable disease per RECIST 1.1 with modifications - There must be radiographically visible tumor - Subjects with only ascites, pericardial, or pleural effusion are excluded • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, neoadjuvant chemotherapy with interval surgery, bevacizumab or extended therapy administered after surgical or non-surgical assessment. - Subjects are allowed to have received, but are not required to have received, 2 additional cytotoxic regimens for management of recurrent or persistent disease • ECOG performance status 0 or 1 (see Appendix H) • Adequate hematological, renal and hepatic function • Left ventricular ejection fraction (LVEF) ≥ institutional lower limit of normal |
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E.4 | Principal exclusion criteria |
Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer • Subjects treated with pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy • Subjects with primary platinum-refractory disease - Subjects with recurrence or progression during the first 6 cycles or < 6 months after the beginning of the first-line platinum-based chemotherapy are excluded • Subjects with platinum-free interval (PFI) > 12 months from their last platinum-based therapy • History of arterial or venous thromboembolism within 12 months prior to randomization • History of central nervous system metastasis • Clinically significant cardiac disease within 12 months prior to randomization • Uncontrolled hypertension, defined as diastolic blood pressure > 90 mmHg OR systolic blood pressure > 140 mmHg |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival (PFS) (Full list of end-points is provided in the protocol and synopsis) |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
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 | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 | No |
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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The end of study will occur 60 months after the last subject is randomized and completed treatment by that date or completed the safety follow-up if past that date (For additional details refer to the protocol). |
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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 | 8 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |