臨床研究等提出・公開システム

Date of registration	June. 20, 2019
Last modified on	May. 19, 2021
Trial ID	jRCT2080224739

Scientific Title	A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4635 in Japanese Patients With Advanced Solid Malignancies
Public Title	A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4635 in Japanese Patients With Advanced Solid Malignancies

Completion Date or Terminated date	April. 27, 2021
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	No
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	AstraZeneca KK
	Address	-
	Phone Number	-
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

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

Recruitment Status	completed

Date of First Enrolment		July. 18, 2019
Target Sample Size		12
Study Type		Interventional
Study Design	Study Design	Single Group Assignment, Open Label
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Adult subjects; age 20 years or more - Histologically or cytological confirmation of a solid, malignant tumor, excluding central nervous system (CNS) tumors and lymphoma, that is refractory to standard therapy or for which no standard of care regimen currently exists - Patients must have either at least one lesion that can be evaluable using RECIST v1.1 or patients with mCRPC must have measurable prostate specific antigen above normal limits (per local ranges) - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Normotensive or well controlled blood pressure, with or without current antihypertensive treatment - Females of child-bearing potential must use 2 highly effective methods of contraception - Male patients should be willing to use barrier contraception
	Exclusion Criteria	- Any investigational medicinal product or other systemic anticancer treatment within at least 4 weeks prior to the first dose of study treatment, or within 8 weeks after immunotherapy or other long half-life antibody therapy, whichever is the most appropriate and as judged by the Investigator - Evidence of recent or significant cardiovascular disease - Unresolved toxicities from prior therapy greater than CTCAE Grade 1 at starting study treatment - History of seizures, CNS tumors or CNS metastasis - Active or prior documented autoimmune or inflammatory disorders within the past 3 years to the start of treatment - Patients with prior Grade3 immune-mediated reactions or more - Evidence of severe or uncontrolled systemic diseases - Inadequate bone marrow reserve or organ function - Refractory nausea and vomiting, chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of AZD4635 - History of hypersensitivity to AZD4635 or drugs with a similar chemical structure or class to AZD4635 - Judgment by the Investigator that the patient should not participate in the study
	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 : AZD4635 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : AZD4635 taken orally control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety -
Secondary Outcome		efficacy pharmacodynamics -

Primary Sponsor	AstraZeneca KK
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	IRB of the National Cancer Center
Address of IRB	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	July. 03, 2019

Secondary ID No.	NCT03980821
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194816
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	May. 19, 2021	(this page)	Changes
2	April. 22, 2020	Detail	Changes
1	June. 26, 2019	Detail

List of change history