Safety Study of MG1102 in Patients With Solid Tumors

NCT ID: NCT01809912

Last Updated: 2015-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Greenstatin

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 .

Group Type: EXPERIMENTAL

Recombinant human apolipoprotein(a) Kringle V

Intervention Type: DRUG

Interventions

Recombinant human apolipoprotein(a) Kringle V

Intervention Type: DRUG

Other Intervention Names

Greenstatin

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Solid tumors refractory to conventional therapy or the subject does not tolerate the conventional therapy
• Evaluable disease or at least one measurable tumor mass by a radiographic technique
• Life expectancy ≥3 months
• Suitable for intravenous administration of study medication
• Signed written informed consent
• Adequate bone marrow, renal, and liver function
• Coagulation profile with aPTT and INR, each ≤ 1.5 x ULN
• No evidence of active Hepatitis B or Hepatitis C infection
• Proteinuria <100 mg
• ECOG performance status ≤2
• Female subjects must agree to use contraceptive measures
• Negative serum ß-hCG
• Ability and willingness to comply with the study protocol

Exclusion Criteria

• Pregnant or lactating women
• Therapy with systemic anticoagulant or antithrombotic agentswithin 7 days prior to first dose
• Hemoptysis within 3 months prior to first dose
• Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks prior to first dose
• Surgery or visceral biopsy within 28 days prior to first dose
• Minor surgical procedure performed within 7 days prior to first dose
• Prior exposure to MG1102
• Known history of HIV
• With active bacterial infections and/or receiving systemic antibiotics
• Current or past diagnosis of leukemia
• Known CNS metastases or clinical evidence of CNS
• Non-healing wound within past 2 weeks
• Bleeding diathesis or bleeding within 14 days prior to enrollment
• Clinically significant thrombosis
• Non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease
• History of idiopathic or hereditary angioedema
• History of sickle cell or any hemolytic anemia
• Require hemoglobin, WBC, or platelet transfusion support or use of hematopoietic growth factors within 2 weeks prior to entry
• Uncontrolled hypertension
• History of clinically significant renal disease
• History of significant medical illness of cardiac or CNS disease within the past 6 months
• Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
• Medical or psychiatric illness
• Recreational substance use or psychiatric illness
• Known hypersensitivity to MG1102 or components of the formulation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

hyunchul chung, dr

Role: PRINCIPAL_INVESTIGATOR

Yonsei Cancer Center

Locations

Yonsei Cancer Center, Yonsei University Severance Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

MG1102_001

Identifier Type: -

Identifier Source: org_study_id