NCT03438708

Prior Axitinib as a Determinant of Outcome of Renal Surgery

"PADRES" (Prior Axitinib as a Determinant of Outcome of REnal Surgery)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II study of axitinib in patients with clear cell renal cell carcinoma (RCC) with strong indications for partial nephrectomy (PN) for whom PN is not currently possible due to anatomic considerations and residual renal function concerns. Evaluation of tumor downsizing will be performed including changes of tumor complexity by nephrometry score. A total of 50 participants will be enrolled. It is hypothesized that pretreatment with axitinib will be safe and improve the feasibility of complex nephron sparing surgery in select patients with localized clear cell RCC and imperative indications for partial nephrectomy.

Detailed description

The primary objective of the study is to prospectively assess utility of axitinib in facilitation of partial nephrectomy where partial nephrectomy was not thought to be safe/possible in the setting of imperative indication for complex renal masses in renal cell cancer. Secondary objectives: To determine the safety, tumor diameter (per RECIST v1.1) volume change, surgical morbidity and renal functional outcomes following neoadjuvant axitinib for RCC. Anatomical/morphometric: 1. tumor diameter/volume change, 2. conversion of hilar to non-hilar tumors, 3. reduction in RENAL morphometric score. Functional Considerations: 1. Requirement of acute dialysis 2. Change in Glomerular Filtration Rate (GFR) 3. Whether or not GFR crosses 30 threshold, or decline by GFR to \>50% of baseline. Safety indices: 1. Incidence of Clavien \>3 complications 2. Avoidance of need for multiple blood transfusions

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Axitinib Oral Tablet [Inlyta]	Axitinib 5 milligrams (mg) administered orally (po) twice daily (BID) for 8 weeks (with titration to 7 mg BID as tolerated at 4 weeks)

Timeline

• Start date: 2018-03-05
• Primary completion: 2026-03-04
• Completion: 2026-03-04
• First posted: 2018-02-20
• Last updated: 2025-10-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study