Safety Study of MG1102 in Patients With Solid Tumors
|ClinicalTrials.gov Identifier: NCT01809912|
Recruitment Status : Terminated
First Posted : March 13, 2013
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Recombinant human apolipoprotein(a) Kringle V||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Cohort 1 : 6 mg/m2 Cohort 2 : 12 mg/m2 Cohort 3 : 24 mg/m2 Cohort 4 : 48 mg/m2 Cohort 5 : 96 mg/m2 Cohort 6 : 192 mg/m2 28 Day Course Subjects will receive MG1102 (Recombinant human apolipoprotein(a) Kringle V ) by IV administration on Day 0. If no DLTs are observed during the 6 days following the initial infusion, the same dose will be administered once daily for 5 consecutive days followed by a 2-day rest period three times (over 21 days), completing the course on Day 27.
Additional 21 Day Courses In the absence of a DLT, and in the case of stable disease or better, a subject may continue to receive MG1102 (Recombinant human apolipoprotein(a) Kringle V
) on a compassionate use basis at the same dose and regimen .
Drug: Recombinant human apolipoprotein(a) Kringle V
Other Name: Greenstatin
- To investigate the safety and tolerability IV MG1102 [ Time Frame: A minimum of 9 weeks ]Adverse events, physical examinations, vital signs, ECGs, clinical laboratory evaluations, lipid profiles
- Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102 [ Time Frame: for 25 days ]
- standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102 [ Time Frame: A minimum of 10 weeks ]
- Determination of response assessed by RECIST v1.1 and Choi criteria to obtain preliminary information regarding the efficacy of MG1102 [ Time Frame: A minimum of 11 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809912
|Korea, Republic of|
|Yonsei Cancer Center, Yonsei University Severance Hospital|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||hyunchul chung, dr||Yonsei Cancer Center|