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Neoadjuvant Axitinib in Locally Advanced Clear Cell RCC
NCT01263769Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2011
- Primary completion
- Feb 2021
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- axitinib
- Conditions
- clear cell renal cell carcinoma (ccRCC)
01
Overview
Phase 2, open-label, single-arm trial of axitinib in clear cell renal cell carcinoma (ccRCC), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Objective Response Rate at 12 weeks. Started Feb 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Axitinib
Axitinib 5 mg BID for 12 weeks followed by surgery
03
Who it enrols
Adult patients with locally advanced clear cell renal cell carcinoma (cT2-T3b, N0, M0) who are candidates for radical nephrectomy and have not received prior systemic therapy.
04
Endpoints
Primary
Objective Response Rate
Secondary
Recurrence Free Survival
Overall Survival
Postoperative Complications-Any Grade
Surgery-related Complications - High Grade
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