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An open label, single institution, phase II study of the mTOR inhibitor temsirolimus in unresectable and/or metastatic renal cell carcinoma (RCC) in patients previously treated with both cytokines and one ore more tyrosine kinase inhibitor, The TeRCC study - ND

An open label, single institution, phase II study of the mTOR inhibitor temsirolimus in unresectable and/or metastatic renal cell carcinoma (RCC) in patients previously treated with both cytokines and one ore more tyrosine kinase inhibitor, The TeRCC study - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-007045-12-IT
Enrollment
Unknown
Registered
2008-01-11
Start date
2008-02-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma

Interventions

Trade Name: Torisel Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Temsirolimus CAS Number: 162635-04-3 Concentration unit: mg/ml milligram(s)/millilitre Concen

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: age >/= 18 years, cyto-hystological diagnosis of renal cell carcinoma, previous treatment with both cytokines and one or more kinase inhibitors, measurable disease, ... Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Major surgical procedure within 28 days prior to study treatment start, other malignancies within the last 5 years, clinically significant cardiovascular disease, myocardial infarction, unstable angina, history of other disease, metabolic disfunction, concomitant radiotherapy in the site of disease, previous radiotherapy or other locoregional antitumoral treatment performed within 21 days before the study recruitment, uncontrolled hyperglicemia, ...

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate the efficacy of single-agent Temsirolimus in patients with previously-treated metastatic renal cell carcinoma based on response rate;Secondary Objective: to determine progression-free survival and overall survival of single-agent temsirolimus; to characterize the safety profile of single-agent Temsirolimus in pre-treated RCC patients;Primary end point(s): response rate—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026