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Clear Cell Renal Cell CarcinomaPhase 2PADRESNCT03438708

Prior Axitinib as a Determinant of Outcome of Renal Surgery

A Phase 2 study testing Axitinib Oral Tablet [Inlyta] in people with Clear Cell Renal Cell Carcinoma, run by University of California, San Diego at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
Axitinib Oral Tablet [Inlyta]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
5 Mar 2018to 4 Mar 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Localized clear cell renal carcinoma without evidence of distant metastases
  • Imperative indication for nephron sparing surgery
  • Baseline chronic kidney disease (CKD) (stage 3, GFR <60 ml/min/1.73m2), or anatomically or functional solitary kidney (defined by renal scintigraphy of contralateral renal unit with <15% function) or bilateral synchronous disease); and
  • RENAL score ≥10 or proximity to renal hilum (defined as <2 mm away from at least 2 renal hilar vessels-the main artery/vein or first order branches); and
  • Radical nephrectomy would lead to severe CKD (stage 3b, GFR <45 ml/min/1.73m2).
  • Male or female, age ≥ 18 years
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  • Karnofsky performance status ≥ 70.
  • Adequate organ function as defined by:
  • Absolute neutrophil count (ANC) ≥1,000/μL
  • Platelets ≥100,000/μL
  • Hemoglobin ≥9.0 g/dL
  • Serum calcium ≤12.0 mg/dL
  • Serum creatinine ≤1.5 x upper limit of normal (ULN)
  • Total serum bilirubin ≤1.5 x ULN
  • SGOT≤2.5 x ULN and serum glutamic pyruvic transaminase (SGPT) ≤2.5x ULN
  • Signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Who cannot join

  • Presence of metastatic disease on radiographic imaging.
  • Elective indication for nephron sparing surgery
  • Non-clear cell histology
  • Prior systemic treatment of any kind or radiotherapy for RCC
  • NCI CTCAE Version 5.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
  • Ongoing cardiac dysrhythmias of NCI CTCAE Version 5.0 grade ≥2. Controlled atrial fibrillation is permitted. Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening EKG >480 msec.
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  • Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal,or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
  • Uncontrolled hypertension (HTN): systolic blood pressure ≥150 or diastolic blood pressure ≥ 100 mmHg or both despite appropriate therapy.
  • HTN with need for greater than three anti-hypertensive agents at baseline. Drug formulations containing two or more anti-hypertensive agents will be counted based on the number of active agents in each formulation.
  • New York Heart Association (NYHA) class III or greater congestive heart failure (CHF)
  • Uncontrolled hyper- or hypothyroidism.
  • Subjects with arterial thrombotic events in the prior 12 months (axitinib has never been studied in this population)
  • Subjects who have had venous thrombotic events in the prior 6 months (axitinib has never been studied in this population)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Axitinib Oral Tablet [Inlyta]
Keywords
Renal Cell Carcinoma, Axitinib, Nephrectomy, Neoadjuvant, Clear Cell Renal Carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axitinib Oral Tablet [Inlyta]Drug

    Also called 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)

Study groups in NCT03438708
Study groupRoleWhat they receive
Axitinib Oral Tablet [Inlyta]ExperimentalAxitinib 5 mg PO BID for 8-10 weeks
Receives: Drug: Axitinib Oral Tablet [Inlyta]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent reduction of longest diameter of tumor in millimeters

    Measured by CT or MRI

    Measured: 90 days

  2. Objective Tumor Response Rate (by RECIST criteria)

    Percentage of patients achieving partial response (reduction in tumor diameter by at least 30% of maximum diameter) as defined by RECIST criteria

    Measured: 90 days

  3. 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]

    The RENAL nephrometry score quantifies tumor size and location relative to the major blood vessel and collecting system supply of the kidney according to 5 domains (tumor radius, exophytic/endophytic appearance, proximity to urinary collecting system, anterior/posterior location, and location with respect to renal poles). Four of these domains have a score of 1-3, with 3 indicating a more complex score within the domain. The total score is the sum of all of the domains (total minimum score being 4 and the maximum score being 12, and with more complex tumors having a higher score). The study will record effect of the medication on tumor complexity as measured by total RENAL nephrometry score.

    Measured: 90 days

  4. Feasibility of partial nephrectomy surgery

    Percentage of Successful partial nephrectomy perfomed (as opposed to radical nephrectomy) with negative surgical margins determined by pathological assessment of resection margins.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2018
  2. Study start5 Mar 2018
  3. Primary completion4 Mar 2026 (estimated)
  4. Study completion4 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03438708
Sponsor's protocol ID
161197
Other IDs
WI209751
Acronym
PADRES
Status last verified
Sep 2025
First submitted
19 Jan 2018
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rini BI, Campbell SC, Escudier B. Renal cell carcinoma. Lancet. 2009 Mar 28;373(9669):1119-32. doi: 10.1016/S0140-6736(09)60229-4. Epub 2009 Mar 5.

    PubMed 19269025

  • Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.

    PubMed 24399786

  • Russo P. End stage and chronic kidney disease: associations with renal cancer. Front Oncol. 2012 Apr 2;2:28. doi: 10.3389/fonc.2012.00028. eCollection 2012.

    PubMed 22649783

  • Kane CJ, Mallin K, Ritchey J, Cooperberg MR, Carroll PR. Renal cell cancer stage migration: analysis of the National Cancer Data Base. Cancer. 2008 Jul 1;113(1):78-83. doi: 10.1002/cncr.23518.

    PubMed 18491376

  • Lee HJ, Liss MA, Derweesh IH. Outcomes of partial nephrectomy for clinical T1b and T2 renal tumors. Curr Opin Urol. 2014 Sep;24(5):448-52. doi: 10.1097/MOU.0000000000000081.

    PubMed 24921904

  • Brandao LF, Zargar H, Autorino R, Akca O, Laydner H, Samarasekera D, Krishnan J, Haber GP, Stein RJ, Kaouk JH. Robot-assisted partial nephrectomy for >/= 7 cm renal masses: a comparative outcome analysis. Urology. 2014 Sep;84(3):602-8. doi: 10.1016/j.urology.2014.04.015. Epub 2014 Jun 12.

    PubMed 24929947

  • Karellas ME, O'Brien MF, Jang TL, Bernstein M, Russo P. Partial nephrectomy for selected renal cortical tumours of >/= 7 cm. BJU Int. 2010 Nov;106(10):1484-7. doi: 10.1111/j.1464-410X.2010.09405.x.

    PubMed 20518765

  • Breau RH, Crispen PL, Jimenez RE, Lohse CM, Blute ML, Leibovich BC. Outcome of stage T2 or greater renal cell cancer treated with partial nephrectomy. J Urol. 2010 Mar;183(3):903-8. doi: 10.1016/j.juro.2009.11.037. Epub 2010 Jan 18.

    PubMed 20083271

  • Long CJ, Canter DJ, Kutikov A, Li T, Simhan J, Smaldone M, Teper E, Viterbo R, Boorjian SA, Chen DY, Greenberg RE, Uzzo RG. Partial nephrectomy for renal masses >/= 7 cm: technical, oncological and functional outcomes. BJU Int. 2012 May;109(10):1450-6. doi: 10.1111/j.1464-410X.2011.10608.x. Epub 2012 Jan 5.

    PubMed 22221502

  • Kopp RP, Mehrazin R, Palazzi KL, Liss MA, Jabaji R, Mirheydar HS, Lee HJ, Patel N, Elkhoury F, Patterson AL, Derweesh IH. Survival outcomes after radical and partial nephrectomy for clinical T2 renal tumours categorised by R.E.N.A.L. nephrometry score. BJU Int. 2014 Nov;114(5):708-18. doi: 10.1111/bju.12580. Epub 2014 Oct 3.

    PubMed 24274650

  • Alanee S, Nutt M, Moore A, Holland B, Dynda D, Wilber A, El-Zawahry A. Partial nephrectomy for T2 renal masses: contemporary trends and oncologic efficacy. Int Urol Nephrol. 2015 Jun;47(6):945-50. doi: 10.1007/s11255-015-0975-3. Epub 2015 Apr 12.

    PubMed 25864101

  • Kopp RP, Liss MA, Mehrazin R, Wang S, Lee HJ, Jabaji R, Mirheydar HS, Gillis K, Patel N, Palazzi KL, Wan JY, Patterson AL, Derweesh IH. Analysis of Renal Functional Outcomes After Radical or Partial Nephrectomy for Renal Masses >/=7 cm Using the RENAL Score. Urology. 2015 Aug;86(2):312-9. doi: 10.1016/j.urology.2015.02.067. Epub 2015 Jul 16.

    PubMed 26189330

  • Randall JM, Millard F, Kurzrock R. Molecular aberrations, targeted therapy, and renal cell carcinoma: current state-of-the-art. Cancer Metastasis Rev. 2014 Dec;33(4):1109-24. doi: 10.1007/s10555-014-9533-1.

    PubMed 25365943

  • Thomas AA, Rini BI, Lane BR, Garcia J, Dreicer R, Klein EA, Novick AC, Campbell SC. Response of the primary tumor to neoadjuvant sunitinib in patients with advanced renal cell carcinoma. J Urol. 2009 Feb;181(2):518-23; discussion 523. doi: 10.1016/j.juro.2008.10.001. Epub 2008 Dec 18.

    PubMed 19100579

  • Cowey CL, Amin C, Pruthi RS, Wallen EM, Nielsen ME, Grigson G, Watkins C, Nance KV, Crane J, Jalkut M, Moore DT, Kim WY, Godley PA, Whang YE, Fielding JR, Rathmell WK. Neoadjuvant clinical trial with sorafenib for patients with stage II or higher renal cell carcinoma. J Clin Oncol. 2010 Mar 20;28(9):1502-7. doi: 10.1200/JCO.2009.24.7759. Epub 2010 Feb 16.

    PubMed 20159822

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Axitinib Oral Tablet [Inlyta] in people with Clear Cell Renal Cell Carcinoma, run by University of California, San Diego at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent reduction of longest diameter of tumor in millimeters (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03438708, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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