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Phase 2 Open-label Study of Rucaparib in Locally Advanced or Metastatic Urothelial Carcinoma
2017-004166-10Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2018
- Countries
- 1
- Sponsor
- Clovis Oncology
- Modality
- Small Molecules
- Drugs
- rucaparib
- Conditions
- transitional cell carcinoma (TCC)
01
Overview
Phase 2, open-label, single-arm trial of rucaparib in transitional cell carcinoma (TCC), sponsored by Clovis Oncology. Primary endpoint: Objective Response Rate (ORR). Started Mar 2018; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Rucaparib monotherapy
Single-group arm in which all enrolled patients receive rucaparib for locally advanced or metastatic urothelial carcinoma.
03
Who it enrols
Adult patients with histologically or cytologically confirmed locally advanced or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra); prior treatment with any PARP inhibitor is an exclusion.
04
Endpoints
Primary
Objective Response Rate (ORR)
Secondary
Secondary efficacy endpoints
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