Safety Study of MG1102 in Patients With Solid Tumors

NCT01809912 | Terminated Phase 1 DMC

• 1 other identifier: MG1102_001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

solid tumor

Outcome Measures

Primary Outcomes (1)

• To investigate the safety and tolerability IV MG1102

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

  A minimum of 9 weeks

Secondary Outcomes (3)

• Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102

  for 25 days

• standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102

  A minimum of 10 weeks

• Determination of response assessed by RECIST v1.1 and Choi criteria to obtain preliminary information regarding the efficacy of MG1102

  A minimum of 11 weeks

Study Arms (1)

Greenstatin

EXPERIMENTAL

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

Interventions

Recombinant human apolipoprotein(a) Kringle V DRUG

Also known as: Greenstatin

Greenstatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Corporation: lead
• ICON Clinical Research: collaborator

Study Sites (1)

Yonsei Cancer Center, Yonsei University Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Study Officials

• hyunchul chung, dr

  Yonsei Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: March 13, 2013
• Study Start: November 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 26, 2015

Record last verified: 2014-01

Locations

KR (1)