臨床研究等提出・公開システム

Date of registration	Oct. 06, 2008
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220617

Scientific Title	A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety and Tolerability of AZD0530 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	Open Label, Single Group Assignment, Safety Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Accepts Healthy Volunteers: No -Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists. -World Health Organisation (WHO) performance status 0 to 2. -Life expectancy of at least 12 weeks.
	Exclusion Criteria	-Inadequate bone marrow reserve. -Inadequate liver function, renal function or low hemoglobin. -Unresolved toxicity from anti-cancer therapy.
	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 : AZD0530 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test. Time Frame: Assessed on an ongoing basis after starting daily dosing with AZD0530 Designated as safety issue: Yes
Secondary Outcome		-To determine the single and multiple dose PK of AZD0530 when administered orally to patients with advanced solid malignancies by assessment of Cmin, Cmax, tmax, Cssmax, Cssmin, AUC0-t, AUC0-24, AUC, AUCss0-24, CL/F, t1/2 and R Time Frame: 1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days. Designated as safety issue: No

Primary Sponsor	AstraZeneca
Secondary Sponsor

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

Secondary ID No.	JapicCTI-080640
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 20, 2016	Detail	Changes
7	Dec. 16, 2016	Detail	Changes
6	Sept. 02, 2011	Detail	Changes
5	Sept. 02, 2011	Detail	Changes
4	Nov. 04, 2009	Detail	Changes
3	Nov. 04, 2009	Detail	Changes
2	Oct. 06, 2008	Detail	Changes
1	Oct. 06, 2008	Detail

List of change history