Spots Global Cancer Trial Database for A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
Official Title: A Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT03646071
Interventions
Study Description
Brief Summary: RX108 is a novel, potent, small-molecule inhibitor of Na+/K+-ATPase. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of RX108 in patients with locally advanced or metastatic solid tumors.
Detailed Description: This is a open-label, two-part study comprised of a dose escalation part and a dose expansion part. In the dose escalation part, RX108 will be administered in ascending doses to evaluate the safety and tolerability of RX108 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). The dose expansion part will assess the safety, pharmacokinetics, and efficacy of RX108 at the RP2D.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai, Los Angeles, California, United States
University of Texas at MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Lyon Gleich, MD
Affiliation: Medpace, Inc.
Role: STUDY_DIRECTOR
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