E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
1. progressed ovarian epithelial cancer 2. primary peritoneal 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 | 10033128 |
E.1.2 | Term | Ovarian cancer |
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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 |
The primary objective of the study is to demonstrate the progression free survival – PFS. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is time to progression – TTP, duration of response, overall survival – OS, clinical benefit – CB = CR + PR + SD, safety and tolerability (adverse events, toxicity, vital signs, laboratory abnormalities). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Female patient ≥ 18 years old. 2. Histologically or cytologically confirmed ovarian epithelial or primary peritoneal cancer. 3. Recurrent or refractory disease. 4. Prior chemotherapy regimens (e.g., initial chemotherapy platinum-based and 1 regimen for subsequent relapse or due to resistance for initial CHT). Each subject must receive regimen based on platinum analogs (carboplatin AUC 5-6 or cisplatin 75 mg/ m2) and paclitaxel based regimen. It could be patients with refractory ovarian cancer (< 6 months to relapse or progression or without any clinical response) or sensitive (> 6 months), the prior chemotherapy must be finished at least 4 weeks before starting of sorafenib treatment. 6. If measurable disease is in a previously irradiated site, there must be disease progression in that lesion 6 months after completion of radiotherapy. 7. ECOG performance status 0 – 2. 8. Female patients must be using effective contraception, be surgically sterile or be postmenopausal. All at-risk female patients must have a negative serum pregnancy test within 7 days prior to study drug administration. 9. Patients with adequate bone marrow, liver and renal function. 10. Signed informed consent must be obtained prior to any study specific procedures.
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E.4 | Principal exclusion criteria |
1. Known or suspected allergy to the investigational agent or any agent given in association with the trial. 2. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta,Tis,T1) or any cancer curatively treated >3 years prior to study entry. 3. History of cardiac disease. 4. History of HIV infection or chronic hepatitis B or C. 5. Active clinically serious infections. 6. Symptomatic metastatic brain ot meningeal tumors 7. Seizure disorders requiring medications. 8. History of organ allograft or patients undergoing renal dialysis 9. Thrombotic or embolic events. 10.Pregnant or breast-feeding patients.
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of progression free survival. |
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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 | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | No |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |