E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients >18 years with relapsed or resitant peripheral T-cell lymphoma, defined as having progressed on 1st or 2nd line therapy. |
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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 | 10042973 |
E.1.2 | Term | T-cell lymphoma NOS recurrent |
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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 | 10042974 |
E.1.2 | Term | T-cell lymphoma NOS refractory |
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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 | 10042979 |
E.1.2 | Term | T-cell lymphoma recurrent |
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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 | 10042980 |
E.1.2 | Term | T-cell lymphoma refractory |
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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 assesse the effect of Nexavar measured as progression-free-survival |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of Nexavar measured as overall-response-rate, clinical benefit rate, duration of response rate of subjects being progression free at 3, 6 and 12 months. Assess the safety of Nexavar, measured by adverse events, laboratory findings, vital signs and rate of serious infections. Analyses of biomarker expressions at screening, 3 months, end of treatment and end of study.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Relapsed or resistant disease (progression on 1st or 2nd line therapy) Confirmed histopatological diagnosis of peripheral T-cell NHL according to WHO classification > 18 years ECOG performance status 0-2 Life expectancy at least 12 weeks At least 1 lymph node or nodal mass >1.5 cm Adequate bone marrow, liver and renal function Signed informed consent
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E.4 | Principal exclusion criteria |
History of cardiac disease History of HIV infection or cronic hepatitis B or C Active clinically serious infections Symptomatic metastatic brain or meningeal tumors Seizure disorders requiring medication History of organ allograft Evidence or history of bleeding diasthesis Renal dialysis Previoius or concurrent cancer, except cervical carcinoma in situ, treated basal squamaos cell skin carcinoma, superficial bladder tomours or any cancer curatively treated >3 years Patients eligable for curative therapy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free-survival, defined as the time from study medication until progressive disease or death as a result of any cause.
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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 | Information not present in EudraCT |
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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End of study (LPLV) is after 1 year of treatment follow-up. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |