Papillary Renal Cell CarcinomaPhase 2AXIPAPNCT02489695
Axitinib in1st Line Treatment for Patients With Advanced or Metastatic Papillary Renal Cell Carcinoma
A Phase 2 study testing Axitinib in people with Papillary Renal Cell Carcinoma, run by Centre Leon Berard at 10 sites in France.
Trial summary
Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Renal Cell Carcinoma
- What is being tested?
- Axitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 10 sitesFrance
- Study dates
- Oct 2015to Jul 2019
- 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
- Age ≥ 18 years.
- Metastatic or locally advanced (inoperable) pure type 1 or 2 or mixed PRCC, histologically confirmed by central review: relevant slides [and blocks if available] with the initial histology report must be sent for central reading before confirmation of inclusion.
- No prior systemic treatment for metastatic renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation).
- At least one measurable site of disease as defined by RECIST 1.1 criteria.
- ECOG performance status of 0, 1.
- No toxicity > 1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
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- In case of prior radiation therapy, discontinuation of irradiation for at least 4 weeks before first dose of study treatment. This period can be reduced to at least 1 week in case of radiotherapy in a limited field (< 10% of the whole body) while no side effects grade ≥ 2 is expected and keeping at least one site for evaluation.
- Adequate bone marrow, liver and renal function, as defined below:
- Absolute neutrophil count ≥ 1.5 G/L, platelet count ≥ 100 G/L, and hemoglobin ≥ 9 g/dL),
- AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) and total bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN if liver metastases),
- Serum creatinine ≤ 2.0 x ULN or creatinine clearance ≥ 50 mL/min according to Cockroft formula or MDRD formula for patients older than 65 years,
- Absence of proteinuria confirmed by urinary dipstick test. If the dipstick test is ≥ 2+, proteinuria will be quantitated on a complete 24h urine sample (< 1 g/L of protein/24h sample).
- Adequate contraceptive methods for fertile female subjects for the whole duration of the study and for 7 days after the last dose of study drug.
- Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.
- Covered by a medical insurance, in countries where applicable.
- Written informed consent before any study specific procedures or assessments.
Who cannot join
- Prior TKI treatment in adjuvant situation for renal cancer.
- Significant cardiovascular disease including:
- Disorder of left ventricular function with a LVEF < 50%,
- Uncontrolled arterial hypertension under adapted medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg or both despite appropriate therapy, or patients under 3 antihypertensive therapies at screening,
- Myocardial infarction, severe angina, or unstable angina within 6 months prior to inclusion,
- History of serious ventricular arrhythmia (ie ventricular tachycardia or ventricular fibrillation),
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- Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication),
- Coronary or peripheral artery bypass graft within 6 months of screening.
- Presence of brain metastases on MRI or CT-scan performed within 28 days prior to inclusion. Patients with a history of brain metastases treated by surgery or stereotactic surgery, with normal brain MRI or CT-scan are allowed to participate.
- Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.
- Any active acute or chronic or uncontrolled infection/disorder that impair the ability to evaluate the patient or the ability for the patient to complete the study.
- Prior history of other malignancies other than PRCC (except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix) unless the subjects has been free of the disease for at least 3 years.
- Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
- Patient included in another clinical trial, except for supportive care trials.
- Psychological, familial, sociological, or geographical conditions that would limit compliance with study protocol requirements.
- Pregnant or breastfeeding women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
ICO Paul Papin
Angers, 49933
Chu Bordeaux
Bordeaux, 33075
Centre Francois Baclesse
Caen, 14076
Centre Geogres François Leclerc
Dijon, 21079
Centre Leon Berard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 13273
ICO - René Gauducheau
Saint-Herblain, 44805
Institut Claudius Regaud
Toulouse, 31059
ICL
Vandœuvre-lès-Nancy, 54519
Gustave Roussy
Villejuif, 94805
About this study
Official title: Multicenter Phase II Study of Axitinib in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line treatment.
Read the detailed description
Renal cell carcinoma (RCC) accounts for 2-3% of all adult malignancies worldwide, representing the seventh most common cancer in men and the ninth in women. The annual incidence is more than 337 000 cases and around 140 000 persons die every year. Half of patients with RCC are going to develop metastases, either with synchronous metastatic sites (25%) or during the follow up (25%).
Papillary renal cell carcinoma (PRCC) represents 10-15% of RCC and is characterized by a cytogenetic profile distinct from other types of renal cancer. Histologically, PRCC could be separated in 2 distinct subtypes: type 1 and type 2.
Vascular endothelial growth factor (VEGF) is a potent induction factor, playing a central role in angiogenesis and vascular permeability of tumor tissues. It binds to three specific receptors: VEGFR-1, VEGFR-2 and VEGFR-3, which are thus implicated in pathologic angiogenesis, tumor growth and metastatic progression of cancer. Patients with papillary histology demonstrated high expression of VEGF and VEGFR-2, making VEGF-targeted therapy an attractive therapeutic option.
Recently, several studies have been developed to assess VEGF targeted therapy in patients with PRCC, mostly with sunitinib and with poor results (median progression-free survival (PFS) around 6 months).
Axitinib is a potent, selective second-generation inhibitor of all three VEGF receptors. By inhibiting VEGF-mediated endothelial cell proliferation and survival, axitinib inhibits angiogenesis and tumor growth.
In phase II trials, axitinib has shown anti-tumor activity with well-tolerated clinical safety profile in patients with advanced solid tumors, including RCC.
Axitinib has been approved for the second-line treatment of advanced RCC on the basis of the pivotal randomized phase III AXIS trial results. 723 patients were enrolled and randomly assigned to receive axitinib or sorafenib. The median PFS assessed by independent review committee was 6.7 months with axitinib compared to 4.7 months with sorafenib (hazard ratio 0.665; 95% CI 0.544-0.812; one-sided p<0.0001).
In all studies, the safety analysis showed a good tolerance of axitinib. The most common adverse reactions (occurring in >20% of treated subjects) were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia and hand-foot skin reaction. Dose discontinuations were reported in 4% of patients with axitinib vs. 8% with sorafenib.
Little clinical data regarding the efficacy of recently developed VEGF targeted therapies in first-line treatment of PRCC is available. To date, there is no standard treatment, and evaluation of efficacy of the new targeted agents is clearly needed.
The purpose of this study is to evaluate the efficacy and safety of axitinib in first-line treatment of patients with papillary renal cell carcinoma.
Axitinib inhibits angiogenesis and vascular permeability in tumor tissues, leading to inhibition of tumor growth.
Axitinib has shown antitumor activity in patients with RCC in phase II and III clinical trials.
VEGF inhibitors are currently used in PRCC treatment, with disappointing results. Axitinib is more potent and selective against the VEGFR family compared with sorafenib and sunitinib in biochemical assays, and could have a similar efficacy with lesser toxicities, therefore may provide a clinical benefit in patients with PRCC.
- Conditions
- Papillary Renal Cell Carcinoma
- Being tested
- Axitinib
- Keywords
- locally advanced or metastatic
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxitinibDrug
axitinib 10mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| axitinib + pembrolizumab | Experimental | axitinib 10mg twice a day Receives: Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of axitinib in first-line treatment of PRCC.
24-week progression-free rate
Measured: 24-week
Secondary outcomes (6)
The safety of axitinib in patients with PRCC (NCI CTCAE v4)
Measured: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
The progression-free survival (RECIST 1.1) in each PRCC subtypes
Measured: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
The overall survival
Measured: 43 month after first inclusion
The best response
the best response recorded from the start of the treatment until disease progression
Measured: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
the objective response rate
Measured: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
the duration of response
Measured: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Papillary Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie NEGRIER, PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489695
- Sponsor's protocol ID
- AXIPAP
- Other IDs
- ET14-090
- Acronym
- AXIPAP
- Status last verified
- Sep 2022
- First submitted
- 19 Jun 2015
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Negrier S, Rioux-Leclercq N, Ferlay C, Gross-Goupil M, Gravis G, Geoffrois L, Chevreau C, Boyle H, Rolland F, Blanc E, Ravaud A, Dermeche S, Flechon A, Albiges L, Perol D, Escudier B; GETUG collaborative group. Axitinib in first-line for patients with metastatic papillary renal cell carcinoma: Results of the multicentre, open-label, single-arm, phase II AXIPAP trial. Eur J Cancer. 2020 Apr;129:107-116. doi: 10.1016/j.ejca.2020.02.001. Epub 2020 Mar 5.
PubMed 32146304de Vries-Brilland M, Rioux-Leclercq N, Meylan M, Dauve J, Passot C, Spirina-Menand E, Flippot R, Fromont G, Gravis G, Geoffrois L, Chevreau C, Rolland F, Blanc E, Lefort F, Ravaud A, Gross-Goupil M, Escudier B, Negrier S, Albiges L. Comprehensive analyses of immune tumor microenvironment in papillary renal cell carcinoma. J Immunother Cancer. 2023 Nov;11(11):e006885. doi: 10.1136/jitc-2023-006885.
PubMed 37935564
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Axitinib in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
- ClinicalTrials.gov ID
- NCT02489695
- Acronym / sponsor ID
- AXIPAP / AXIPAP
- Conditions
- Papillary Renal Cell Carcinoma
- Keywords
- locally advanced or metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 3 Jul 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.
Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line treatment.
Detailed description
Renal cell carcinoma (RCC) accounts for 2-3% of all adult malignancies worldwide, representing the seventh most common cancer in men and the ninth in women. The annual incidence is more than 337 000 cases and around 140 000 persons die every year. Half of patients with RCC are going to develop metastases, either with synchronous metastatic sites (25%) or during the follow up (25%).
Papillary renal cell carcinoma (PRCC) represents 10-15% of RCC and is characterized by a cytogenetic profile distinct from other types of renal cancer. Histologically, PRCC could be separated in 2 distinct subtypes: type 1 and type 2.
Vascular endothelial growth factor (VEGF) is a potent induction factor, playing a central role in angiogenesis and vascular permeability of tumor tissues. It binds to three specific receptors: VEGFR-1, VEGFR-2 and VEGFR-3, which are thus implicated in pathologic angiogenesis, tumor growth and metastatic progression of cancer. Patients with papillary histology demonstrated high expression of VEGF and VEGFR-2, making VEGF-targeted therapy an attractive therapeutic option.
Recently, several studies have been developed to assess VEGF targeted therapy in patients with PRCC, mostly with sunitinib and with poor results (median progression-free survival (PFS) around 6 months).
Axitinib is a potent, selective second-generation inhibitor of all three VEGF receptors. By inhibiting VEGF-mediated endothelial cell proliferation and survival, axitinib inhibits angiogenesis and tumor growth.
In phase II trials, axitinib has shown anti-tumor activity with well-tolerated clinical safety profile in patients with advanced solid tumors, including RCC.
Axitinib has been approved for the second-line treatment of advanced RCC on the basis of the pivotal randomized phase III AXIS trial results. 723 patients were enrolled and randomly assigned to receive axitinib or sorafenib. The median PFS assessed by independent review committee was 6.7 months with axitinib compared to 4.7 months with sorafenib (hazard ratio 0.665; 95% CI 0.544-0.812; one-sided p<0.0001).
In all studies, the safety analysis showed a good tolerance of axitinib. The most common adverse reactions (occurring in >20% of treated subjects) were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia and hand-foot skin reaction. Dose discontinuations were reported in 4% of patients with axitinib vs. 8% with sorafenib.
Little clinical data regarding the efficacy of recently developed VEGF targeted therapies in first-line treatment of PRCC is available. To date, there is no standard treatment, and evaluation of efficacy of the new targeted agents is clearly needed.
The purpose of this study is to evaluate the efficacy and safety of axitinib in first-line treatment of patients with papillary renal cell carcinoma.
Axitinib inhibits angiogenesis and vascular permeability in tumor tissues, leading to inhibition of tumor growth.
Axitinib has shown antitumor activity in patients with RCC in phase II and III clinical trials.
VEGF inhibitors are currently used in PRCC treatment, with disappointing results. Axitinib is more potent and selective against the VEGFR family compared with sorafenib and sunitinib in biochemical assays, and could have a similar efficacy with lesser toxicities, therefore may provide a clinical benefit in patients with PRCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| axitinib + pembrolizumab | Experimental | Drug: Axitinibaxitinib 10mg twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years.
- Metastatic or locally advanced (inoperable) pure type 1 or 2 or mixed PRCC, histologically confirmed by central review: relevant slides [and blocks if available] with the initial histology report must be sent for central reading before confirmation of inclusion.
- No prior systemic treatment for metastatic renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation).
- At least one measurable site of disease as defined by RECIST 1.1 criteria.
- ECOG performance status of 0, 1.
Key exclusion criteria (16 listed)
- Prior TKI treatment in adjuvant situation for renal cancer.
- Significant cardiovascular disease including:
- Presence of brain metastases on MRI or CT-scan performed within 28 days prior to inclusion. Patients with a history of brain metastases treated by surgery or stereotactic surgery, with normal brain MRI or CT-scan are allowed to participate.
- Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.
- Any active acute or chronic or uncontrolled infection/disorder that impair the ability to evaluate the patient or the ability for the patient to complete 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 |
|---|---|---|
| Axitinibaxitinib 10mg twice a day | Drug | axitinib + pembrolizumab |
Primary outcome
The efficacy of axitinib in first-line treatment of PRCC.
Time frame: 24-week
24-week progression-free rate
6 secondary outcomes
The safety of axitinib in patients with PRCC (NCI CTCAE v4)
Time frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
The progression-free survival (RECIST 1.1) in each PRCC subtypes
Time frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
The overall survival
Time frame: 43 month after first inclusion
The best response
Time frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
the objective response rate
Time frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
the duration of response
Time frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18
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 Sep 2022.
- Background: PubMed 32146304Negrier S, Rioux-Leclercq N, Ferlay C, Gross-Goupil M, Gravis G, Geoffrois L, Chevreau C, Boyle H, Rolland F, Blanc E, Ravaud A, Dermeche S, Flechon A, Albiges L, Perol D, Escudier B; GETUG collaborative group. Axitinib in first-line for patients with metastatic papillary renal cell carcinoma: Results of the multicentre, open-label, single-arm, phase II AXIPAP trial. Eur J Cancer. 2020 Apr;129:107-116. doi: 10.1016/j.ejca.2020.02.001. Epub 2020 Mar 5.
- Derived from this study: PubMed 37935564de Vries-Brilland M, Rioux-Leclercq N, Meylan M, Dauve J, Passot C, Spirina-Menand E, Flippot R, Fromont G, Gravis G, Geoffrois L, Chevreau C, Rolland F, Blanc E, Lefort F, Ravaud A, Gross-Goupil M, Escudier B, Negrier S, Albiges L. Comprehensive analyses of immune tumor microenvironment in papillary renal cell carcinoma. J Immunother Cancer. 2023 Nov;11(11):e006885. doi: 10.1136/jitc-2023-006885.
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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.
Sylvie NEGRIER, PhD principal investigator
Centre Leon Berard
10 sites 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 Papillary Renal Cell Carcinoma, run by Centre Leon Berard at 10 sites 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 16 inclusion and 16 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 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 efficacy of axitinib in first-line treatment of PRCC. (time frame: 24-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489695, which also lists 2 linked publications.
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 Sep 2022.