臨床研究等提出・公開システム

Date of registration	Mar. 18, 2008
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220530

Scientific Title	A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly in Japanese Adult 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	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Ages Eligible for Study: 20 Years to 75 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Inclusion Criteria: -Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments. -Patients who usually have mild symptoms capable of walking and light and sedentary work. -Patients who can stay in hospital at least during 4 weeks. Exclusion Criteria: -Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin. -Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function. -Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Cancer, Tumors, Carcinoma
Intervention(s)		investigational material(s) Generic name etc : AZD4877 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
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-080540
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Dec. 15, 2016	Detail	Changes
5	Dec. 15, 2016	Detail	Changes
4	Sept. 15, 2010	Detail	Changes
3	Sept. 15, 2010	Detail	Changes
2	Mar. 18, 2008	Detail	Changes
1	Mar. 18, 2008	Detail

List of change history