A Phase I, Multicenter Study of MRX34 Given Intravenously Two Times Per Week for Three Weeks, Repeated Every Four Weeks in Patients With Unresectable Primary Liver Cancer or Advanced or Metastatic Cancer With Liver Involvement
This is a Phase I, open-label, multicenter, dose-escalation study to investigate the safety,
Pharmacokinetics and Pharmacodynamics of the micro ribonucleic acid (microRNA) MRX34, in
patients with unresectable primary liver cancer or advanced or metastatic cancer with liver
involvement. MRX34 will be administered IV twice a week for 3 weeks with 1 week off (total
28 days) as a single agent.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The maximum tolerated dose (MTD) for MRX34 and the recommended phase 2 dose (RPh2D)
Dose-limiting toxicity (DLT) in 3-6 patients at the end of one treatment cycle
One year
Yes
Andrew Brenner, PhD, MD
Principal Investigator
UTHSCSA/CTRC
United States: Food and Drug Administration
MRX34-101
NCT01829971
April 2013
August 2014
Name | Location |
---|---|
Virginia G. Piper Cancer Center | Scottsdale, Arizona 85724 |
Ut Southwestern Medical Center | Dallas, Texas 75390 |
Uthscsa/Ctrc | San Antonio, Texas 78229 |