E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced or recurrent endometrial carcinoma |
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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 |
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E.2.2 | Secondary objectives of the trial |
Progression free survival overall survival Toxicity |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Advanced endometrial cancer (stage III-IV), not considered for treatment modalities apart from hormonal treatment • Relapse after primary treatment with interval > 1 month • Measurable tumour by X-ray examination and/or CT and/or MRI outside irradiated area. • Histological verified endometrial cancer. Only patients with tumors of endometrioid type will be accepted. • Post-menopausal women • Expected survival > 6 month • Age must be at least 18 years • Performance status must be 0-2 (WHO/ECOG, appendix I) • Informed consent given according to ICH/EU GCP guidelines and local or national laws
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E.4 | Principal exclusion criteria |
• Congestive heart failure grade III-IV • Severe hepatic or renal impairment not allowing for adequate use of the proposed regimens. ASAT or ALAT > 4 times of the upper limit of the normal values. S-Creatinine >150 mmol/l • Other malignancies within the last 5 years apart from cancer in situ cervicis uteri or basal cell carcinoma of the skin. • History of tromboembolic signs. • Any treatment that interact with the study drug like carbamazepine or cyclosporine. • Other primary hormonal therapy. • Tumors consisting of or with elements of serous papillary (UPSC) or clear cell type. • Inclusion in other trials. • Any cancer treatment or use of any investigation agent within one month of the study entry. • Circumstances at the time of the entry that would not permit completion of the study or follow-up. • Patients with symptomatic brain metastases. • Pregnancy, lactation or child bearing potential patients without adequate contraception • Dementia or significantly altered status that would prohibit the understanding and giving of informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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) | 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 | No |
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 | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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The trial end when the last recruited patient experience progression |
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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 | 4 |
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 | 4 |