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

2014-07-23 21:11:21 | BioPortfolio

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.

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

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 12.6 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Cell Carcinoma

Intervention

Everolimus, BNC105P, Everolimus, BNC105P

Location

Indiana University Simon Cancer Center
Indianapolis
Indiana
United States
46202

Status

Recruiting

Source

Hoosier Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:21-0400

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