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Sunitinib with or without Gemcitabine in Advanced Renal Cell Carcinoma With Sarcomatoid Features
NCT01164228Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2010
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Modality
- Small Molecules
- Drugs
- gemcitabine
- Conditions
- renal cell carcinoma (RCC)
01
Overview
Phase 2, randomised, open-label trial of gemcitabine in renal cell carcinoma (RCC) (2 arms), sponsored by ECOG-ACRIN Cancer Research Group. Primary endpoint: Proportion of Patients With Response at 36 months. Started Sep 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm A (Sunitinib + Gemcitabine)
Gemcitabine IV on days 1, 8, 22, 29 and oral sunitinib once daily on days 1-14 and 22-35 of a 42-day cycle.
Arm B (Sunitinib)
Oral sunitinib once daily on days 1-14 and 22-35 of a 42-day cycle.
03
Who it enrols
Patients with advanced renal cell carcinoma with sarcomatoid features, ECOG PS 0-2, adequate organ function, and no more than one prior non-TKI systemic therapy.
04
Endpoints
Primary
Proportion of Patients With Response
Secondary
Progression-free Survival
Overall Survival
Toxic effects
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