CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
sorafenib tosylate +1 moredrug
Likely dose
Sorafenib tosylate 400 mg orally twice dailyAI-extracted
Key inclusion· 8
  • ✓Histologically or cytologically confirmed transitional cell cancer of bladder, renal pelvis, or ureter
  • ✓Measurable disease ≥20 mm by conventional techniques or ≥10 mm by spiral CT
  • ✓No prior systemic therapy for advanced/metastatic disease; prior adjuvant/neoadjuvant chemotherapy allowed if completed ≥4 weeks prior
  • ✓Radiation therapy allowed if completed >4 weeks prior
Key exclusion· 10
  • ✕Prior systemic therapy for advanced or metastatic urothelial carcinoma
  • ✕Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to study entry
  • ✕Only non-measurable disease (bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis, etc.)
  • ✕Known brain metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112671
NCT00112671Phase 2Completed
CompareCT.gov

A Phase II Study of BAY 43-9006 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter and Renal Pelvis)

National Cancer Institute (NCI)·interventional·Posted Jun 3, 2005·Updated Jul 27, 2018

In Brief

A Phase 2 clinical trial evaluating sorafenib tosylate and laboratory biomarker analysis for Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter and 6 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed Summary

This phase II trial is studying how well sorafenib works in treating patients with advanced or metastatic cancer of the urinary tract. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Regional Transitional Cell Cancer of the Renal Pelvis and Ureter, Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2005
Enrollment StartApr 1, 2005
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 21.1 years ago

Interventions

sorafenib tosylatedrug

Given orally 400mg orally twice daily

laboratory biomarker analysisother

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