There is an increasing trend in the burden of renal cell carcinoma (RCC) globally. Although different therapies like tyrosine kinase inhibitors, ablative therapy, surgery, and immunotherapy have been suggested for RCC, they are not cost-effective. The present study will be conducted as an open-label, phase Ib/II study consisting of a dose-escalation stage followed by a cohort expansion stage. The trial will be conducted in the medical centers affiliated to the Tabriz University of Medical Sciences. Patients 18 years or older presenting with histologically confirmed RCC with a clear-cell component, that progressed to the advanced or metastatic stage will be recruited. The dose-escalation stage will determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of sodium pentaborate pentahydrate. One oral sodium pentaborate pentahydrate capsule once daily will be considered for evaluation in 21-day treatment cycles: 500 mg, 1000 mg, and 1500 mg. Subjects will accrue in escalation cohorts of 3-6 subjects using a 3 plus 3 design and dosing will begin at the 500 mg dose level of sodium pentaborate pentahydrate. During this stage, the decision to open a new cohort will be made when all subjects have been followed for at least 21 days following the first dose of sodium pentaborate pentahydrate(defined as the dose-limiting toxicity (DLT) Evaluation Period). In the dose-expansion stage, we will further assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of NaB in RCC using the recommended dose and schedule as determined in the dose-escalation stage. The primary objectives for the dose-escalation stage and dose-expansion stage will be to determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent expansion stage and to evaluate the preliminary efficacy of the sodium pentaborate pentahydrate by estimating the objective response rate, respectively. The investigator will assess each subject continuously to evaluate for potential new or worsening adverse events.
This study investigates the safety and efficacy of sodium pentaborate pentahydrate in patients with advanced renal cell carcinoma.