Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340040
• Other study ID #: D5621C00006
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2011
• Last updated: December 10, 2014
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Research Site	Matsuyama	Ehime

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination	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.	Yes
Secondary	Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies)	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	No
Secondary	Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST)	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	No
Secondary	Pharmacokinetics, - Cmax	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.	No
Secondary	Pharmacokinetics,- Cmax at steady state (Cmax, ss)	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.	No
Secondary	Pharmacokinetics - time to maximum concentration (tmax)	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.	No
Secondary	Pharmacokinetics, - terminal elimination rate constant (?z)	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.	No
Secondary	Pharmacokinetics - (AUC(0-t))	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.	No
Secondary	Pharmacokinetics - total clearance and terminal phase (Vz) 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.	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	No
Secondary	Pharmacodynamics: - Insulin-like growth factor (IGF)-I and IGF-II on circulating plasma levels 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.	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	No

External Links

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