cT2a N0NxM0 Renal TumorPhase 2AXIPANNCT02597322
Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)
A Phase 2 study testing AXITINIB in people with cT2a N0NxM0 Renal Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- cT2a N0NxM0 Renal Tumor
- What is being tested?
- AXITINIB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- cT2a N0NxM0 Renal Tumor
- Being tested
- AXITINIB
- Keywords
- Axitinib, T2a Renal tumor, organ confined tumors, nephron sparing surgery, nephron sparing procedure, radical nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXITINIBDrug
Also called AG013736
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.
| Study group | Role | What they receive |
|---|---|---|
| AXITINIB | Experimental | Not described Receives: Drug: AXITINIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm
Measured: At 6 months after beginning of the treatment
Secondary outcomes (5)
Response rate according to RECIST criteria
Measured: 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.
Measured: At 30 months after beginning of the treatment
Renal function assessed by serum creatinin
Measured: At baseline and at 30 months after beginning of the treatment
Renal function assessed by calculated glomerular filtration rate (GFR) according to MDRD formula
Measured: At baseline and at 30 months after beginning of the treatment
Renal function assessed by renal scintigraphy
Measured: At baseline and at 30 months after beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startFeb 2012
- Primary completionNov 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cT2a N0NxM0 Renal TumorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jean Jacques Patard, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597322
- Sponsor's protocol ID
- P110209
- Acronym
- AXIPAN
- Status last verified
- Mar 2017
- First submitted
- 8 Jun 2015
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02597322
- Acronym / sponsor ID
- AXIPAN / P110209
- Conditions
- cT2a N0NxM0 Renal Tumor
- Keywords
- Axitinib, T2a Renal tumor, organ confined tumors, nephron sparing surgery, nephron sparing procedure, radical nephrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXITINIB | Experimental | Drug: AXITINIB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXITINIBAlso: AG013736Axitinib 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. | Drug | AXITINIB |
Primary outcome
The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm
Time frame: At 6 months after beginning of the treatment
5 secondary outcomes
Response rate according to RECIST criteria
Time frame: 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.
Time frame: At 30 months after beginning of the treatment
Renal function assessed by serum creatinin
Time frame: At baseline and at 30 months after beginning of the treatment
Renal function assessed by calculated glomerular filtration rate (GFR) according to MDRD formula
Time frame: At baseline and at 30 months after beginning of the treatment
Renal function assessed by renal scintigraphy
Time frame: At baseline and at 30 months after beginning of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Jacques Patard, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AXITINIB in people with cT2a N0NxM0 Renal Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm (time frame: At 6 months after beginning of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.