臨床研究等提出・公開システム

Date of registration	Dec. 28, 2016
Last modified on	Mar. 15, 2021
Trial ID	jRCT2080223424

Scientific Title	A Phase 1 Study of DS-1001b in Patients with IDH1 Mutated Gliomas
Public Title	A Phase 1 Study of DS-1001b in Patients with IDH1 Mutated Gliomas

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Jan. 19, 2017
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	Multicenter, non-randomized, open-label
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1) Subjects must have histologically confirmed glioma with an IDH1-R132 mutation. 2) Subjects must have disease that has recurred or progressed following standard treatment including radiation therapy. 3) Subjects must have measurable lesion(s) as per RANO criteria. 4) Subjects must have ECOG PS of 0 to 2.
	Exclusion Criteria	1) Subjects with significant symptoms of increased intracranial pressure. 2) Subjects who have active another neoplasm. 3) Subjects with active infection requiring systemic treatment. 4) Subjects with a history of severe cardiac disease 5) Subjects who have received prior treatment with any therapy targeting mutant IDH1. 6) Subjects who have received other investigational drug treatment within 3 weeks prior to the first dose of study treatment. 7) Female subjects who are pregnant or breast feeding.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Glioma
Intervention(s)		investigational material(s) Generic name etc : DS-1001b INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral 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		other To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of DS-1001b
Secondary Outcome		safety efficacy pharmacokinetics pharmacodynamics 1) To assess the safety and tolerability of DS-1001b 2) To characterize the pharmacokinetic (PK) profile of DS-1001b 3) To characterize the pharmacodynamic (PDy) effect of DS-1001b on 2-HG levels 4) To assess the preliminary anti-tumor activity of DS-1001b Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group.

Primary Sponsor	DAIICHI SANKYO CO., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Nagoya University Hospital Institutional Review Board
Address of IRB	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Dec. 21, 2016

Secondary ID No.	NCT03030066
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-163479
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
11	Mar. 15, 2021	(this page)	Changes
10	June. 04, 2020	Detail	Changes
9	Feb. 27, 2020	Detail	Changes
8	April. 10, 2019	Detail	Changes
7	Dec. 17, 2018	Detail	Changes
6	Feb. 23, 2018	Detail	Changes
5	Feb. 23, 2018	Detail	Changes
4	Feb. 01, 2017	Detail	Changes
3	Feb. 01, 2017	Detail	Changes
2	Dec. 28, 2016	Detail	Changes
1	Dec. 28, 2016	Detail

List of change history