Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| cT2a N0NxM0 Renal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AXITINIB | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AXITINIB
- interventionNames
- Drug: AXITINIB
Primary outcomes (1)
- measure
- The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm
- timeFrame
- At 6 months after beginning of the treatment
Secondary outcomes (5)
- measure
- Response rate according to RECIST criteria
- timeFrame
- At 30 months after beginning of the treatment
- measure
- Number of participants with treatment-related serious adverse events and their grades according to CTCAE V4.0.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available