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

NCT02597322 | Completed Phase 2

• 1 other identifier: P110209
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

cT2a N0NxM0 Renal Tumor

Keywords

Axitinib; T2a Renal tumor; organ confined tumors; nephron sparing surgery; nephron sparing procedure; radical nephrectomy

Outcome Measures

Primary Outcomes (1)

• The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm

  At 6 months after beginning of the treatment

Secondary Outcomes (5)

• Response rate according to RECIST criteria

  At 30 months after beginning of the treatment

• Number of participants with treatment-related serious adverse events and their grades according to CTCAE V4.0.

  At 30 months after beginning of the treatment

• Renal function assessed by serum creatinin

  At baseline and at 30 months after beginning of the treatment

• Renal function assessed by calculated glomerular filtration rate (GFR) according to MDRD formula

  At baseline and at 30 months after beginning of the treatment

• Renal function assessed by renal scintigraphy

  At baseline and at 30 months after beginning of the treatment

Study Arms (1)

AXITINIB

EXPERIMENTAL

Drug: AXITINIB

Interventions

AXITINIB DRUG

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.

Also known as: AG013736

AXITINIB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must sign IRB/EC-approved informed consent.
• Age ≥ 18
• Histologically proven clear cell RCC (obtained by CT or US guided biopsy)
• cT2a N0NxM0 Renal tumor according to 2009 TNM classification (tumor Ø\> 7cm; ≤ 10 cm)
• No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
• Normal renal function (MDRD creatinin clearance ≥ 60 ml/min)
• Patients must have adequate organ function defined as: Platelets ≥ 150 x 109/L, hemoglobin \> 9 g/dl, absolute neutrophil count (ANC) \>1.5 x 109/L; Bilirubin \< 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal; Total cholesterol ≤ 9.1 mmol/l and triglyceride level ≤ 4.5 mmol/l
• Urinary protein \<2+ by urine dipstick.
• Patients with reproductive potential must use medically acceptable contraceptive method.
• Beneficiary of a social coverage (except AME)

You may not qualify if:

• Patients with \< 50 % clear cell histology
• Evidence of locally advanced disease: cT stage≥T2b, N Stage≥1 or metastatic disease (M1)
• Patients must not be pregnant or lactating.
• Patients must not have uncompensated coronary artery disease or an history of myocardial infarction or severe or unstable angina within the past six months or severe diabetes mellitus with severe arterial peripheral disease or deep venous or arterial thrombosis or embolism with the past 3 months. Patients must not need curative anticoagulants.
• Patients must not have any medical/systemic or psychiatric disorder incompatible with the study.
• Patients must not have a history of significant gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of Axitinib or an unavailability of the oral route.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Pfizer: collaborator

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Interventions

Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jean Jacques Patard, MD, PhD

  Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: November 5, 2015
• Study Start: February 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2017
• Last Updated: April 6, 2025

Record last verified: 2017-03

Locations

FR (1)