Clinical trial · Interventional
The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium
A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy
NCT01801137CI-TRIAL-00022643AFINIVESTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus (Afinitor®) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Afinitor
- description
- Treatment by Afinitor 10 mg per day
- interventionNames
- Drug: Everolimus (Afinitor®)
Primary outcomes (1)
- measure
- Progression-free survival rate at 12 weeks
- timeFrame
- 3 months
- description
- If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of written informed consent * Male or female aged more than 18 years * Histologically proven transitional cell carcinoma of the urothelium * Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy * Recurrence or progression after at least one chemotherapy regimen and for unresectable/advanced disease * No more than 2 lines of previous chemotherapy.. * Measurable disease (RECIST criteria) * Previously irradiated lesions are not considered measurable- ECOG performance status of 0, 1 or 2 Exclusion Criteria: * No prior treatment with anti cancer agents, including radiotherapy, in the last 4 weeks. * No currently active CNS involvement * No pregnancy. Women of child bearing potential must have a negative pregnancy test. * No uncontrolled diabetes * No symptomatic coronary artery disease, myocardial infarction within the last six months, congestive cardiac failure greater than New York Heart Association (NYHA) class II, uncontrolled or symptomatic cardiac arrhythmia
References
Publications (0)
Data not yet available
No reference posted for this study.