Renal Cell Carcinoma Patients MedDRA version: 14.0 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TORISEL 30 mg, concentrado y disolvente para solución para perfusión.
Pharmaceutical Form: Concentrate and diluent for solution for infusion
INN or Proposed INN: TEMSIROLIMUS
CAS Number: 1
Sponsors
Fundación Hospital Clinic i Provincial
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Metastatic renal or locally advanced RCC histologically confirmed - Patients who will received Temsirolimus as the habitual clinical practice. - ECOG =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the Pharmacokinetic profile of temsirolimus ?and sirolimus- after an intravenous 25 mg/week administration.;Secondary Objective: - 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;Primary end point(s): To describe the Pharmacokinetic profile of temsirolimus ?and sirolimus- after an intravenous 25 mg/week administration.;Timepoint(s) of evaluation of this end point: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
Spain
Contacts
Public ContactTFS - Yolanda Martín
TFS
Outcome results
None listed