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Axitinib in1st Line Treatment for Patients With Advanced or Metastatic Papillary Renal Cell Carcinoma (AXIPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489695
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief 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.

Condition or disease Intervention/treatment Phase
Papillary Renal Cell Carcinoma Drug: axitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study of Axitinib in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
Actual Study Start Date : October 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: axitinib
axitinib 10mg twice a day
Drug: axitinib
Other Name: Inlyta




Primary Outcome Measures :
  1. The efficacy of axitinib in first-line treatment of PRCC. [ Time Frame: 24-week ]
    24-week progression-free rate


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. The overall survival [ Time Frame: 43 month after first inclusion ]
  4. The best response [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]
    the best response recorded from the start of the treatment until disease progression

  5. the objective response rate [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]
  6. the duration of response [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. 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.
  3. No prior systemic treatment for metastatic renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation).
  4. At least one measurable site of disease as defined by RECIST 1.1 criteria.
  5. ECOG performance status of 0, 1.
  6. No toxicity > 1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
  7. 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.
  8. 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,
  9. 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).
  10. 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.

  11. Covered by a medical insurance, in countries where applicable.
  12. Written informed consent before any study specific procedures or assessments.

Exclusion Criteria:

1- 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),
  • 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.

    3- 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.

    4- Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.

    5- 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.

    6- 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.

    7- Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.

    8- Patient included in another clinical trial, except for supportive care trials.

    9- Psychological, familial, sociological, or geographical conditions that would limit compliance with study protocol requirements.

    10- Pregnant or breastfeeding women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489695


Locations
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France
ICO Paul Papin
Angers, France, 49933
Chu Bordeaux
Bordeaux, France, 33075
Centre Francois Baclesse
Caen, France, 14076
Centre Geogres François Leclerc
Dijon, France, 21079
Centre Leon Berard
Lyon, France, 69373
Institut Paoli Calmettes
Marseille, France, 13273
ICO - René Gauducheau
Saint-herblain, France, 44805
Institut Claudius Regaud
Toulouse, France, 31059
ICL
Vandoeuvre-les-nancy, France, 54519
Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Sylvie NEGRIER, PhD Centre Leon Berard
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02489695    
Other Study ID Numbers: AXIPAP
ET14-090 ( Other Identifier: Centre Léon Bérard )
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Keywords provided by Centre Leon Berard:
locally advanced or metastatic
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action