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The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
Full description
OUTLINE: This is a multi-center study.
Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design, 21-day cycle
Dose Level 1 Everolimus 10 mg BNC105P 4.2 mg/m2 Dose Level 2 Everolimus 10 mg BNC105P 8.4 mg/m2 Dose Level 3 Everolimus 10 mg BNC105P 12.6 mg/m2 Dose Level 4 Everolimus 10 mg BNC105P 16 mg/m2
Phase II: Patients will be randomized 1:1 to Arm A or Arm B
Combination Arm A: Everolimus 10 mg + BNC105P MTD (from Phase 1 study) 21 day cycle
Sequential Arm B: Everolimus 10 mg 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Karnofsky Performance Score (KPS) ≥70 within 7 days prior to registration for protocol therapy.
Life Expectancy: Not specified
Hematopoietic:
White blood cell count (WBC) > 3.5 K/mm3 Hemoglobin (Hgb) > 8.5 g/dL Platelets > 100 K/mm3 Absolute neutrophil count (ANC) > 1.5 K/mm3
Hepatic:
Total Bilirubin < 1.25 x ULN Aminotransferase (AST and ALT) < 2.5 x ULN
Renal:
Serum Creatinine < 2.5 x ULN (upper limit normal)
Cardiovascular:
No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy No history of clinical CHF or LVEF <50% by Echo (or MUGA) within 30 days prior to registration for protocol therapy.
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154 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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