Track topics on Twitter Track topics that are important to you
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.
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
- 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
- Total Bilirubin < 1.25 x ULN
- Aminotransferase (AST and ALT) < 2.5 x ULN
- Serum Creatinine < 2.5 x ULN (upper limit normal)
- 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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Renal Cell Carcinoma
Everolimus, BNC105P, Everolimus, BNC105P
Indiana University Simon Cancer Center
Hoosier Oncology Group
Published on BioPortfolio: 2014-07-23T21:11:21-0400
A Phase I Trial of BNC105P in combination with BTK inhibitor ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia(CLL). This study proposes that ibrutinib will have ...
The purpose of this study is to determine if certain features of tumor specimens sampled prior to therapy can predict for the likelihood of responding to everolimus.
This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. ...
Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in patients. T...
To assess whether daily treatment with everolimus can slow the growth and spread of metastatic carcinoma of the kidney. The safety of everolimus will also be studied in this trial.
While tacrolimus and everolimus have common metabolic pathways through CYP3A4/5, tacrolimus is metabolized solely by CYP3A4 in recipients with the/. The purpose of this study was to evaluate how the a...
Purpose In the phase III METEOR trial ( ClinicalTrials.gov identifier: NCT01865747), 658 previously treated patients with advanced renal cell carcinoma were randomly assigned 1:1 to receive cabozantin...
The mammalian target of rapamycin (mTOR) pathway is a critical target for cancer treatment and the mTOR inhibitor everolimus (RAD001) has been approved for treatment of renal cell carcinoma (RCC). How...
Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation. In a multicenter noninferiority tr...
Many centers implement everolimus-based immunosuppression in liver transplant patients with hepatocellular carcinoma. We aimed to explore the potential impact of early initiated everolimus on tumor re...
A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.
A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.
An autosomal dominant disorder caused by mutations in a tumor suppressor gene. This syndrome is characterized by abnormal growth of small blood vessels leading to a host of neoplasms. They include HEMANGIOBLASTOMA in the RETINA; CEREBELLUM; and SPINAL CORD; PHEOCHROMOCYTOMA; pancreatic tumors; and renal cell carcinoma (see CARCINOMA, RENAL CELL). Common clinical signs include HYPERTENSION and neurological dysfunctions.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A rare tumor of the female genital tract, most often the ovary, formerly considered to be derived from mesonephric rests. Two varieties are recognized: (1) clear cell carcinoma, so called because of its histologic resemblance to renal cell carcinoma, and now considered to be of muellerian duct derivation and (2) an embryonal tumor (called also ENDODERMAL SINUS TUMOR and yolk sac tumor), occurring chiefly in children. The latter variety may also arise in the testis. (Dorland, 27th ed)