CompletedPhase 2

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

France44 participantsStarted 2015-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)
✓. 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:

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

The efficacy of axitinib in first-line treatment of PRCC.

Timeframe: 24-week

Trial details

NCT IDNCT02489695

SponsorCentre Leon Berard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07

View on ClinicalTrials.gov More Papillary Renal Cell Carcinoma trials