E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Renal Cell Carcinoma Patients |
Pacientes con carcinoma de células renales. |
|
E.1.1.1 | Medical condition in easily understood language |
Renal Cell Carcinoma Patients |
Pacientes con carcinoma de células renales. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067946 |
E.1.2 | Term | Renal cell carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 describe the Pharmacokinetic profile of temsirolimus ?and sirolimus- after an intravenous 25 mg/week administration. |
Describir el perfil farmacocinético de temsirolimus (TemSRL) -y sirolimus (SRL) - tras una administración intravenosa de 25 mg/semana. |
|
E.2.2 | Secondary objectives of the trial |
- To determine if micromolar levels are achieved and maintained, during the interval therapeutic range, in the tumor and/or surrogate tissue with a 25 mg/week IV administration. - To determine the relation lymphocyte levels and tissue/tumor levels. - To evaluate the correlation between TemSRL +SRL whole blood levels and TemSRL +SRL intracellular (Tcell) concentrations. - To evaluate the correlation between TemSRL +SRL whole blood levels and TemSRL +SRL tissue concentrations. - To establish a correlation between drug concentration and mTOR pathway inhibition - To establish a correlation between clinical response and drug concentration |
- Determinar si los niveles micromolares se logran y mantienen durante el rango del intervalo terapeútico, en tumor y/o en células mononucleares (linfocitos) con una administración intravenosa de 25 mg/semana. - Determinar la relación entre los niveles de TemSRL + SRL intralinfocitarios y los niveles en tumor. - Evaluar la correlación entre los niveles de TemSRL +SRL en sangre completa y las concentraciones intracelulares (Tcel) de TemSRL +SRL - Evaluar la correlación entre los niveles de TemSRL +SRL en sangre completa y las concentraciones en el tumor de TemSRL +SRL - Establecer una correlación entre la concentración de fármaco y la inhibición de la vía mTOR - Establecer una correlación entre la respuesta clínica y la concentración del fármaco |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Metastatic renal or locally advanced RCC histologically confirmed - Patients who will received Temsirolimus as the habitual clinical practice. - ECOG < 2 - Correct serum blood cell count and biochemistry |
- CCR metastático o localmente avanzado y confirmado histológicamente. - Pacientes que reciban Temsirolimus según la práctica clínica habitual. - ECOG < 2 - Correcto recuento de células sanguíneas y bioquímica |
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E.4 | Principal exclusion criteria |
- Patients who do not met inclusion criteria - Patients with active infection - Patients with HIV infection - Patients receiving high dose corticosteroids or other inmunosupressive agents |
- Pacientes que no reúnan los criterios de inclusión - Pacientes con una infección activa - Pacientes con una infección de VIH - Pacientes que estén recibiendo altas dosis de corticoesteroides u otros agentes inmunosupresores |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To describe the Pharmacokinetic profile of temsirolimus ?and sirolimus- after an intravenous 25 mg/week administration. |
Describir el perfil farmacocinético de temsirolimus (TemSRL) -y sirolimus (SRL) - tras una administración intravenosa de 25 mg/semana. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- To determine if micromolar levels are achieved and maintained, during the interval therapeutic range, in the tumor and/or surrogate tissue with a 25 mg/week IV administration. - To determine the relation lymphocyte levels and tissue/tumor levels. - To evaluate the correlation between TemSRL +SRL whole blood levels and TemSRL +SRL intracellular (Tcell) concentrations. - To evaluate the correlation between TemSRL +SRL whole blood levels and TemSRL +SRL tissue concentrations. - To establish a correlation between drug concentration and mTOR pathway inhibition - To establish a correlation between clinical response and drug concentration |
- Determinar si los niveles micromolares se logran y mantienen durante el rango del intervalo terapeútico, en tumor y/o en células mononucleares (linfocitos) con una administración intravenosa de 25 mg/semana. - Determinar la relación entre los niveles de TemSRL + SRL intralinfocitarios y los niveles en tumor. - Evaluar la correlación entre los niveles de TemSRL +SRL en sangre completa y las concentraciones intracelulares (Tcel) de TemSRL +SRL - Evaluar la correlación entre los niveles de TemSRL +SRL en sangre completa y las concentraciones en el tumor de TemSRL +SRL - Establecer una correlación entre la concentración de fármaco y la inhibición de la vía mTOR - Establecer una correlación entre la respuesta clínica y la concentración del fármaco |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
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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Last subject Last visit |
Última visita del último paciente |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |