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Axitinib Oral Tablet [Inlyta] for Renal Cell Carcinoma (PADRES Trial)

Phase 2
Waitlist Available
Led By Brian I Rini, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

PADRES Trial 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.

Eligible Conditions
  • Renal Cell Carcinoma

PADRES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect on tumor morphometry, as measured by RENAL score [(R)adius, (E)xophytic/endophytic components, (N)earness to the collecting system or sinus, (A)neterior/posterior, and (L)ocation relative to polar lines]
Feasibility of partial nephrectomy surgery
Objective Tumor Response Rate (by RECIST criteria)
+1 more

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02129647
30%
Mucositis
10%
Fatigue
10%
Rash
10%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axitinib

PADRES Trial Design

1Treatment groups
Experimental Treatment
Group I: Axitinib Oral Tablet [Inlyta]Experimental Treatment1 Intervention
Axitinib 5 mg PO BID for 8-10 weeks

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,123 Previous Clinical Trials
1,552,789 Total Patients Enrolled
The Cleveland ClinicOTHER
1,030 Previous Clinical Trials
1,365,508 Total Patients Enrolled
Brian I Rini, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
54 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
CA: A Cancer Journal for CliniciansJournal
Cancer Statistics, 2014
Siegel, Rebecca, Jiemin Ma, Zhaohui Zou, and Ahmedin Jemal. 2014. “Cancer Statistics, 2014”. CA: A Cancer Journal for Clinicians. Wiley. doi:10.3322/caac.21208.
European Journal of CancerJournal
New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)
Eisenhauer, E.A., P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, et al.. 2009. “New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2008.10.026.
European UrologyJournal
Phase 2 Trial of Neoadjuvant Axitinib in Patients with Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Karam, Jose A., Catherine E. Devine, Diana L. Urbauer, Marisa Lozano, Tapati Maity, Kamran Ahrar, Pheroze Tamboli, Nizar M. Tannir, and Christopher G. Wood. 2014. “Phase 2 Trial of Neoadjuvant Axitinib in Patients with Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2014.01.035.
clinicaltrials.govStudy
Prior Axitinib as a Determinant of Outcome of Renal Surgery
Ithaar H Derweesh, MD 2018. "Prior Axitinib as a Determinant of Outcome of Renal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03438708.
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~7 spots leftby May 2025
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