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Intravesical CGC for BCG-Refractory Bladder Cancer
NCT02202772Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2014
- Primary completion
- Apr 2026
- Countries
- 1
- Modality
- Allosteric Modulators
- Drugs
- cabazitaxel
- Conditions
- urothelial carcinoma of the bladder (UC)
01
Overview
Phase 2, open-label trial of cabazitaxel in urothelial carcinoma of the bladder (UC) (5 arms). Primary endpoints: Number of serious adverse events associated with therapy at 6 weeks and Number of complete responders at 6 weeks. Started Dec 2014; status: active, not recruiting.
02
Design
5 arms- Study design
- Non-randomizedOpen-label
Gem + Low Cab
Gemcitabine 2000mg + Cabazitaxel 2.5mg
Gem + High Cab
Gemcitabine 2000mg + Cabazitaxel 5mg
Gem + High Cab + Low Cis
Gemcitabine 2000mg + Cabazitaxel 5mg + Cisplatin 66mg
Gem + High Cab + Mod Cis
Gemcitabine 2000mg + Cabazitaxel 5mg + Cisplatin 80mg
Gem + High Cab + High Cis
Gemcitabine 2000mg + Cabazitaxel 5mg + Cisplatin 100mg
03
Endpoints
Primary
Number of serious adverse events associated with therapy
Number of complete responders
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