臨床研究等提出・公開システム

Date of registration	May. 12, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221095

Scientific Title	A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Having advanced solid malignancy for which no curative or standard therapies exist - Karnofsky performance status of 60 or more - Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)
	Exclusion Criteria	- Inadequate bone marrow reserve or organ function - Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures - History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced Solid Malignancies
Intervention(s)		investigational material(s) Generic name etc : MEDI-575 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Administered weekly or every 3-week as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor	MedImmune LLC

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
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Date of Approval by IRB

Secondary ID No.	JapicCTI-101129
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Jan. 12, 2017	Detail	Changes
9	Jan. 12, 2017	Detail	Changes
8	Mar. 11, 2014	Detail	Changes
7	Mar. 11, 2014	Detail	Changes
6	Feb. 14, 2012	Detail	Changes
5	Feb. 14, 2012	Detail	Changes
4	May. 28, 2010	Detail	Changes
3	May. 28, 2010	Detail	Changes
2	May. 12, 2010	Detail	Changes
1	May. 12, 2010	Detail

List of change history