Status:
TERMINATED
Safety Study of MG1102 in Patients With Solid Tumors
Lead Sponsor:
Green Cross Corporation
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pharmacody...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01809912
Start Date
November 1 2010
End Date
March 1 2013
Last Update
November 26 2015
Active Locations (1)
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1
Yonsei Cancer Center, Yonsei University Severance Hospital
Seoul, Seoul, South Korea, 120-752