Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of MG1102 in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01809912
Recruitment Status : Terminated
First Posted : March 13, 2013
Last Update Posted : November 26, 2015
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Green Cross Corporation

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Recombinant human apolipoprotein(a) Kringle V Phase 1

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 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 .

Drug: Recombinant human apolipoprotein(a) Kringle V
Other Name: Greenstatin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102 [ Time Frame: for 25 days ]
  2. standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102 [ Time Frame: A minimum of 10 weeks ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809912


Locations
Layout table for location information
Korea, Republic of
Yonsei Cancer Center, Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Green Cross Corporation
ICON Clinical Research
Investigators
Layout table for investigator information
Principal Investigator: hyunchul chung, dr Yonsei Cancer Center

Layout table for additonal information
Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01809912     History of Changes
Other Study ID Numbers: MG1102_001
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: January 2014

Keywords provided by Green Cross Corporation:
solid tumor

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms