NCT01829971

A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Mirna Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Liver Cancer
• SCLC
• Lymphoma
• Melanoma
• Multiple Myeloma
• Renal Cell Carcinoma
• NSCLC

Interventions

Type	Name	Description
DRUG	MRX34	micro RNA therapy

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-03-01
• Completion: 2017-05-01
• First posted: 2013-04-11
• Last updated: 2016-09-27

Locations

10 sites across 2 countries: United States, South Korea