E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Platinum sensitive recurrent ovarian cancer |
|
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 |
To make a preliminary assessment of the efficacy of pertuzumab in combination with carboplatin-based standard chemotherapy as compared to carboplatin-based standard chemotherapy alone, in patients with platinum-sensitive recurrent ovarian cancer, based on progression-free survival. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the objective response rate (ORR) for each treatment arm as defined by RECIST in patients with measurable disease or by CA 125 (GCIG amendment to RECIST) in all patients. - To evaluate the safety profile of pertuzumab in combination with carboplatin-based standard chemotherapy. - To determine the duration of response, time to progression and the overall survival for both treatment arms. - To evaluate biomarkers that may be associated with clinical benefit due to pertuzumab in combination with carboplatin-based chemotherapy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- ECOG performance status of 0 or 1. - Life expectancy of ≥ 12 weeks. - Histologically confirmed platinum-sensitive recurrent ovarian cancer, as defined by a progression-free interval of greater than 6 months after completion of a platinum-based regimen - Only one previous regimen which must be platinum-based. - At least one measurable lesion according to RECIST or non-measurable disease. If non-measurable disease must have an elevated CA 125 level of ≥ 2 x ULN documented by two measurements. - Availability of paraffin embedded tumor tissue tumor tissue sample for biomarker assessment - Baseline LVEF ≥ 50% (measured by echocardiography or in exceptional cases by MUGA scan). - For women of childbearing potential, a negative pregnancy test must be available and they must use an effective method of contraception. |
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E.4 | Principal exclusion criteria |
- History of CNS metastasis or with clinical evidence of CNS metastases. - Prior radiotherapy. - Inadequate bone marrow, liver function and renal function parameters as described in protocol. Prior treatment with any targeted therapy. - Prior exposure to anthracyclines as defined in protocol. - History of congestive heart failure NYHA grade > 2, unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease. - Patient with serious uncontrolled intercurrent illness - Pregnant or lactating women |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is progression-free survival, defined as the time from date of first dose of study drug (study day 1) to documented disease progression or death, whichever occurs 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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Identification of biomarkers associated with clinical benefit |
|
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 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 |
|
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
|
As described in the protocol, the primary endpoint of the study is progression-free survival which will be analyzed one year after the last patient is enrolled. Therefore the end of study will be one year after the last patient has been enrolled in the trial or when all patients have progressed, died or withdrawn from the trial, whichever is earlier. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
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 |