Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Kidney Neoplasms

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Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Endothelial Growth Factors

Mitogens

Protein Kinase Inhibitors

Enzyme Inhibitors

Axitinib is an oral, potent, and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3 It will be supplied as 1 mg and 5 mg film coated tablets for oral administration in light protecting bottles of 60 tablets.

AXITINIB

Jean Jacques Patard, MD, PhD

Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in phase II study in cytokine-refractory metastatic renal-cell cancer patients.

Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with large organ confined tumors to benefit from NSS.

The Objective is to determine the efficacy of Axitinib administered prior to surgery in patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for shifting from a radical nephrectomy indication to a nephron sparing procedure.

Radical nephrectomy (RN) is the current standard of care for large organ confined renal tumors.

Experience and surgical technical improvements have allowed the feasibility of Nephron Sparing Surgery (NSS) in tumors larger than 4 cm and up to 7cm. Very limited data exist regarding the feasibility and safety of NSS in tumors larger than 7cm.

It has been demonstrated that NSS compared to RN offers similar oncological outcome while better preserving renal function and thus improving overall survival.

The purpose of this study is to test the possibility of offering patients with large organ confined renal tumors, candidates for radical nephrectomy according to current guidelines the benefit of partial nephrectomy thanks to axitinib neo-adjuvant treatment.

Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)

An Open-label, Non-randomized, Multicenter, Two Stage Designed Phase II Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)

Pfizer

Assistance Publique - Hôpitaux de Paris

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)	NCT02597322	cT2a N0NxM0 Ren...	AXITINIB	18 Years -	Assistance Publique - Hôpitaux de Paris
Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)	NCT02597322	cT2a N0NxM0 Ren...	AXITINIB	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for t2a renal tumor