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

Renal Cell Carcinoma Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

• NCT number: NCT01034631
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2010
• Completion date: December 2016