臨床研究等提出・公開システム

Date of registration	Aug. 13, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220802

Scientific Title	A Phase 1, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
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		45
Study Type		Interventional
Study Design	Study Design	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective - Must be suitable for treatment with gemcitabine - Relatively good overall health other than cancer
	Exclusion Criteria	- Poor bone marrow function (not producing enough blood cells) - Poor liver or kidney function - Serious heart conditions
	Minimum Age	20age old over
	Maximum Age	74age old under
	Gender	Both
Health Condition or Problem Studied		Cancer, Solid Tumors, Advanced Solid Malignancies
Intervention(s)		investigational material(s) Generic name etc : AZD7762, Gemcitabine (Gemzar) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous, weekly
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
Secondary Outcome		- Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine - Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)

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
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090831
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Dec. 20, 2016	Detail	Changes
5	Dec. 20, 2016	Detail	Changes
4	Feb. 23, 2011	Detail	Changes
3	Feb. 23, 2011	Detail	Changes
2	Aug. 13, 2009	Detail	Changes
1	Aug. 13, 2009	Detail

List of change history