Clinical trial · Interventional
SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
NCT00578526CI-TRIAL-00034517SPRUCEcompletedPhase 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)
The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urothelial Cancer | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| SU011248 | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
- interventionNames
- Drug: SU011248
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- 1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract * Mixed histology with predominant TCC allowed. * Failed, intolerant or ineligible for cisplatin based chemo * Measurable Disease (RECIST)Not previously irradiated. * Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0) * No weight loss \>/- 10% within 28 days of day 0 * Adequate Organ Function Exclusion Criteria: * Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma. * Small cell histology * More than one previous systemic chemo * Excised metastases without remaining measureable disease * Prior therapy with angiogenesis inhibitors
References
Publications (0)
Data not yet available
No reference posted for this study.