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Brief Title: A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
Official Title: A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
Study ID: NCT01829971
Brief Summary: This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or other selected solid tumors or hematologic malignancies. The drug is given intravenously, for 5 days in a row and then two weeks off.
Detailed Description: 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 or without liver involvement or hematologic malignancies. MRX34 will be administered daily x 5 with 2 weeks off (total of 21 days) for 3 cycles followed by a no-treatment observation period.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Virginia G. Piper Cancer Center, Scottsdale, Arizona, United States
Mayo Clinic Arizona, Scottsdale, Arizona, United States
Texas Oncology Dallas, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Uthscsa/Ctrc, San Antonio, Texas, United States
Severance Hospital, Yonsie University Health System, Seoul, Seodaemun-Gu, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Name: O'Neill VIncent, MD
Affiliation: Mirna Therapeutics
Role: STUDY_DIRECTOR