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A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With TCC After Failure of Chemotherapy

NCT00714025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-01-24

No results posted yet for this study

Summary

An open-label, single arm, non-randomized, single stage phase II study. 3 phases:Baseline, treatment/duration and Follow-up. All patients will be treated with RAD001 10 mg daily dose until disease progression or unacceptable toxicity death, or discontinuation from the study, for any other reason

Conditions

  • Transitional Cell Carcinoma

Interventions

DRUG

RAD001

RAD001 10mg, daily, PO

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Jean-Pascal H Machiels, MD PhD · Cliniques Universitaires St Luc-UCL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-04-30
Completion
2012-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00714025 on ClinicalTrials.gov