NCT01809912

Safety Study of MG1102 in Patients With Solid Tumors

A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in patients with solid tumors for which no standard therapy is available.

Detailed description

This is an open-label, Dose Escalation Study, multicenter phase I study to evaluate the safety and tolerability, determine the pharmacokinetics, and obtain preliminary information regarding pharmacodynamics and efficacy of MG1102 in subjects with solid tumor. Each subject will receive on dose of MG1102 followed by a 6-day rest period. If the initial dose is tolerated, subject will continue with the 21 days of MG1102 administration (5 days on treatment, 2 days off treatment for 3 weeks.) Subjects that have a tumor response as stable disease, may continue therapy on a compassionate use. Study Duration : for a minimum of 8 weeks

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Recombinant human apolipoprotein(a) Kringle V

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-03-13
• Last updated: 2015-11-26

Locations

1 site across 1 country: South Korea