- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01340040
Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects
December 10, 2014 updated by: AstraZeneca
A Phase 1, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Japanese Subjects With Advanced Solid Tumours Refractory to Standard Therapy or for Which No Standard Therapy Exists
The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ehime
-
Matsuyama, Ehime, Japan
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Japanese men or women at least 20 years of age
- Histological or cytological confirmation of a solid, malignant tumour excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist
- WHO performance status 0-2 with no deterioration over the previous 2 weeks
Exclusion Criteria:
- Previous therapy with medication against IGF (ie, monoclonal antibodies with IGF-1R or IGF-targeting tyrosine kinase inhibitors)
- Inadequate bone marrow reserve or organ function
- Poorly controlled diabetes mellitus as defined by the investigator's assessment and/or glycosylated hemoglobin (HbA1c) reading > 6.5% within 28 days prior to the first dose of MEDI-573
- History of allergy or reaction to any component of the MEDI-573 formulation or drugs with a similar chemical structure or class to MEDI-573
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MEDI-573
|
MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination
Time Frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies)
Time Frame: For Cohorts 1, 2 and 3:day 1 (pre-dose) of every cycle; 30 days after the last dose; 3 months after the last dose
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3:day 1 (pre-dose) of every cycle; 30 days after the last dose; 3 months after the last dose
|
Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST)
Time Frame: Tumor assessment by RECIST 1.1 every 2 cycles
|
subjects who discontinue the study treatment for reasons other than disease progression or initiation of alternative anticancer therapy will undergo tumor assessment 3 months after the last dose of MEDI-573).
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
Tumor assessment by RECIST 1.1 every 2 cycles
|
Pharmacokinetics, - Cmax
Time Frame: For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
Pharmacokinetics,- Cmax at steady state (Cmax, ss)
Time Frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
Pharmacokinetics - time to maximum concentration (tmax)
Time Frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
Pharmacokinetics, - terminal elimination rate constant (λz)
Time Frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
Pharmacokinetics - (AUC(0-t))
Time Frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
Pharmacokinetics - total clearance and terminal phase (Vz) of MEDI-573
Time Frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
Pharmacodynamics: - Insulin-like growth factor (IGF)-I and IGF-II on circulating plasma levels of MEDI-573
Time Frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
|
For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Edward Bradley, MD, MedImmune LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
April 11, 2011
First Submitted That Met QC Criteria
April 20, 2011
First Posted (Estimate)
April 21, 2011
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5621C00006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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