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

NCT02597322

Last updated date
Study Location
Bicêtre Hospital
Le Kremlin Bicêtre, , 94275, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
cT2a N0NxM0 Renal Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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cT2a N0NxM0 Renal TumorStudy of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)
NCT02597322
  1. Le Kremlin Bicêtre,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)
Official Title  ICMJE 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)
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.

Detailed Description

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE cT2a N0NxM0 Renal Tumor
Intervention  ICMJE Drug: AXITINIB
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.
Other Name: AG013736
Study Arms  ICMJE Experimental: AXITINIB
Intervention: Drug: AXITINIB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2015)
55
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02597322
Other Study ID Numbers  ICMJE P110209
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jean Jacques Patard, MD, PhDAssistance Publique - Hôpitaux de Paris, Bicêtre Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP