Prior Axitinib as a Determinant of Outcome of Renal Surgery
NCT ID: NCT03438708
Last Updated: 2025-10-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
22 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-05
Study Completion Date
2026-03-04
Brief Summary
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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.
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.
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Detailed Description
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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
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
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Clear Cell Renal Cell Carcinoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Axitinib Oral Tablet [Inlyta]
Axitinib 5 mg PO BID for 8-10 weeks
Group Type
EXPERIMENTAL
Axitinib Oral Tablet [Inlyta]
Intervention Type
DRUG
Axitinib 5 milligrams (mg) administered orally (po) twice daily (BID) for 8 weeks (with titration to 7 mg BID as tolerated at 4 weeks)
Interventions
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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)
Intervention Type
DRUG
Other Intervention Names
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Inlyta
Eligibility Criteria
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Inclusion Criteria
1. Localized clear cell renal carcinoma without evidence of distant metastases
2. 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).
3. Male or female, age ≥ 18 years
4. Karnofsky performance status ≥ 70.
5. 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
6. Signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
2. 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).
3. Male or female, age ≥ 18 years
4. Karnofsky performance status ≥ 70.
5. 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
6. Signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria
1. Presence of metastatic disease on radiographic imaging.
2. Elective indication for nephron sparing surgery
3. Non-clear cell histology
4. Prior systemic treatment of any kind or radiotherapy for RCC
5. NCI CTCAE Version 5.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
6. 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.
7. 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.
8. 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.
9. Uncontrolled hypertension (HTN): systolic blood pressure ≥150 or diastolic blood pressure ≥ 100 mmHg or both despite appropriate therapy.
10. 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.
11. New York Heart Association (NYHA) class III or greater congestive heart failure (CHF)
12. Uncontrolled hyper- or hypothyroidism.
13. Subjects with arterial thrombotic events in the prior 12 months (axitinib has never been studied in this population)
14. Subjects who have had venous thrombotic events in the prior 6 months (axitinib has never been studied in this population)
2. Elective indication for nephron sparing surgery
3. Non-clear cell histology
4. Prior systemic treatment of any kind or radiotherapy for RCC
5. NCI CTCAE Version 5.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
6. 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.
7. 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.
8. 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.
9. Uncontrolled hypertension (HTN): systolic blood pressure ≥150 or diastolic blood pressure ≥ 100 mmHg or both despite appropriate therapy.
10. 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.
11. New York Heart Association (NYHA) class III or greater congestive heart failure (CHF)
12. Uncontrolled hyper- or hypothyroidism.
13. Subjects with arterial thrombotic events in the prior 12 months (axitinib has never been studied in this population)
14. Subjects who have had venous thrombotic events in the prior 6 months (axitinib has never been studied in this population)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Cleveland Clinic
OTHER
Sponsor Role
collaborator
University of California, San Diego
OTHER
Sponsor Role
lead
Responsible Party
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Aditya Bagrodia
Professor of Urology and Radiology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ithaar H Derweesh, MD
Role: STUDY_CHAIR
UC San Diego Moores Cancer Center
Ithaar H Derweesh, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego Moores Cancer Center
Brian I Rini, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Steven C Campbell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
Site Status
Cleveland Clinic
Cleveland, Ohio, United States
Site Status
Countries
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United States
References
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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.
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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.
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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.
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Lane BR, Derweesh IH, Kim HL, O'Malley R, Klink J, Ercole CE, Palazzi KL, Thomas AA, Rini BI, Campbell SC. Presurgical sunitinib reduces tumor size and may facilitate partial nephrectomy in patients with renal cell carcinoma. Urol Oncol. 2015 Mar;33(3):112.e15-21. doi: 10.1016/j.urolonc.2014.11.009. Epub 2014 Dec 19.
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Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4.
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Other Identifiers
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WI209751
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
161197
Identifier Type: -
Identifier Source: org_study_id
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