NCT01034631

BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

Phase I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
DRUG	BNC105P	BNC105P, up to 16 mg/m\^2

Timeline

• Start date: 2010-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2009-12-17
• Last updated: 2022-07-11
• Results posted: 2017-05-24

Locations

108 sites across 3 countries: United States, Australia, Singapore