Histologically confirmed advanced Renal Cell Carcinoma, with non-clear cell pathology. MedDRA version: 14.1 Level: PT Classification code 10038389 Term: Renal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Sutent
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Other descriptive name: SUNITINIB MALATE
Concentration uni
Sponsors
Duke University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed advanced RCC, with non-clear cell pathology. Pathology must consist predominantly (> 50%) of papillary or chromophobe or undifferentiated histology. Mixtures of these non-clear cell variants are allowed. 2. RCC tumor tissue available for correlative sciences, from either primary or metastatic site or both. 3. At the time of screening, at least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 3.0) Grade = 1. 4. Subject must have radiographic evidence of metastatic disease with at least 1 measurable per RECIST 1.1 criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. subjects with a history of or active central nervous system (CNS) metastases. CNS metastases are allowed provided they have been treated and have been stable without new or growing lesions for 6 weeks. 2. Prior systemic therapy for RCC, including mTOR and anti-angiogenic therapy, chemotherapy, biologic or experimental therapy. 3. Collecting duct, medullary, small cell, oncocytoma, or lymphoma-type pathology is not allowed. Sarcomatoid variants of papillary or chromophobe carcinoma is permitted but not if clear cell features are predominant (>50% involvement). 4. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers. Subjects on acceptable CYP3A4 isoenzyme inhibitors and/or inducers are eligible, provided they have been taking a stable regimen for at least 4 weeks prior to screening. 5. Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the screening visit. 6. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint will be a comparison of progression-free survival (PFS) between the treatment arms following therapy initiation. Disease progression is defined by documentation of progressive disease, a new primary malignancy, or death (whichever occurs first), censored at the last tumor evaluation date. ; Secondary Objective: • 6-, 12- and 24-month rates of PFS i • (PFS) expressed compared to an historic control • compare the overall response rate • Compare Stable Disease and Clinical Benefit Rate • Compare overall survival (OS) rates • Compare the best tumor shrinkage • Correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. • Evaluate ichanges in copy number, RNA expression, and immunohistochemical profiles between primary non-clear cell RCC tumors and metastatic samples. • Compare the median duration of response • Compare the median OS • Compare the time-to-new metastatic disease in each treatment arm • Compare change in quality-of-life • Assess toxicities associated with everolimus or sunitinib ;Primary end point(s): The primary endpoint will be a comparison of the rate of progression-free survival (PFS) between the treatment arms at 6 months following therapy initiation. | — |
Countries
United Kingdom
Outcome results
None listed