Overview

SLM + Axitinib for Clear Cell RCC

Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase I/II trial for safety and preliminary efficacy of the combination of axitinib and selenomethionine (SLM) for adult patients with advanced metastatic clear cell renal cell carcinoma (CCRCC). This will be a two part study consisting of a dose escalation and expansion study. In addition, a pilot group of 10 subjects will have SLM dose calculated based on patients' body surface area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Iowa
Yousef Zakharia
Collaborator:
Pfizer
Treatments:
Axitinib
Selenium