Safety Study of MG1102 in Patients With Solid Tumors

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation
• Collaborator: ICON Clinical Research

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