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A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate the safety and tolerability IV MG1102

Outcome Description:

Adverse events, physical examinations, vital signs, ECGs, clinical laboratory evaluations, lipid profiles

Outcome Time Frame:

A minimum of 9 weeks

Safety Issue:

Yes

Principal Investigator

hyunchul chung, dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

MG1102_001

NCT ID:

NCT01809912

Start Date:

November 2010

Completion Date:

July 2013

Related Keywords:

  • Solid Tumors
  • solid tumor
  • Neoplasms

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