臨床研究等提出・公開システム

Date of registration	Sept. 04, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221904

Scientific Title	A Phase 1, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients With Advanced Solid Malignancies Including Malignant Lymphoma
Public Title

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	Safety Study, Single Group Assignment, Open Label
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study - Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist - Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks. - Patients who have at least one lesion that can be accurately assessed
	Exclusion Criteria	- Patients who have recently received or are receiving prohibited medications or treatments - Patients who have any unresolved side effects of previous treatments - Patients who have spinal cord compression or brain metastases - Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection) - Patients with significant abnormal ECG findings
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced Solid Malignancies, Malignant Lymphoma
Intervention(s)		investigational material(s) Generic name etc : AZD1208 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Patients will receive a single dose on Day 1 then after 3 to 7 days washout (minimum 72 hours), multiple dosing will be initiated. Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose.
Health Condition(s) Keyword
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Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

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-121949
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Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	July. 30, 2014	Detail	Changes
6	July. 30, 2014	Detail	Changes
5	Feb. 06, 2013	Detail	Changes
4	Feb. 06, 2013	Detail	Changes
3	Sept. 07, 2012	Detail	Changes
2	Sept. 04, 2012	Detail	Changes
1	Sept. 04, 2012	Detail

List of change history