Solid TumorsPhase 1NCT01809912
Safety Study of MG1102 in Patients With Solid Tumors
A Phase 1 study testing Recombinant human apolipoprotein(a) Kringle V in people with Solid Tumors, run by Green Cross Corporation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Recombinant human apolipoprotein(a) Kringle V
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Cancer Center, Yonsei University Severance Hospital
Seoul, Seoul, 120-752
About this study
Official title: A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS
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.
Read the 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
- Conditions
- Solid Tumors
- Being tested
- Recombinant human apolipoprotein(a) Kringle V
- Keywords
- solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human apolipoprotein(a) Kringle VDrug
Also called Greenstatin
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Drug: Recombinant human apolipoprotein(a) Kringle V |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability IV MG1102
Adverse events, physical examinations, vital signs, ECGs, clinical laboratory evaluations, lipid profiles
Measured: A minimum of 9 weeks
Secondary outcomes (3)
Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102
Measured: for 25 days
standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102
Measured: 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
Measured: A minimum of 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startNov 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- hyunchul chung, dr, Principal investigator, Yonsei Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809912
- Sponsor's protocol ID
- MG1102_001
- Status last verified
- Jan 2014
- First submitted
- 30 Oct 2012
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS
- ClinicalTrials.gov ID
- NCT01809912
- Acronym / sponsor ID
- MG1102_001
- Conditions
- Solid Tumors
- Keywords
- solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Greenstatin | Experimental | Drug: Recombinant human apolipoprotein(a) Kringle VCohort 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human apolipoprotein(a) Kringle VAlso: Greenstatin | Drug | Greenstatin |
Primary outcome
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
3 secondary outcomes
Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102
Time frame: for 25 days
standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102
Time frame: 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
Time frame: A minimum of 11 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hyunchul chung, dr principal investigator
Yonsei Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human apolipoprotein(a) Kringle V in people with Solid Tumors, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety and tolerability IV MG1102 (time frame: A minimum of 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.