A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
NCT ID: NCT04458272
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2020-07-08
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DS-1001b
DS-1001b
250 mg, twice daily, continuous oral administration
Interventions
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DS-1001b
250 mg, twice daily, continuous oral administration
Eligibility Criteria
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Inclusion Criteria
* Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory conducted during the screening period.
* Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy.
* Has at least 1 measurable and non-enhancing lesion.
* Has an interval of at least 90 days from the latest surgery.
* Has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
Exclusion Criteria
* Has had a contrast enhancing lesion on brain MRI.
* Has received a prior treatment with any mutant IDH1 inhibitor.
* Has received other investigational products within 28 days before the start of the study drug treatment.
* Has an active infection requiring systemic treatment.
* Has multiple primary malignancies.
* Has a history of clinically significant cardiac disease.
* Is a pregnant or lactating woman.
20 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Kyorin University Hospital
Tokyo, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Countries
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References
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Natsume A, Arakawa Y, Narita Y, Sugiyama K, Hata N, Muragaki Y, Shinojima N, Kumabe T, Saito R, Motomura K, Mineharu Y, Miyakita Y, Yamasaki F, Matsushita Y, Ichimura K, Ito K, Tachibana M, Kakurai Y, Okamoto N, Asahi T, Nishijima S, Yamaguchi T, Tsubouchi H, Nakamura H, Nishikawa R. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol. 2023 Feb 14;25(2):326-336. doi: 10.1093/neuonc/noac155.
Other Identifiers
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205339
Identifier Type: OTHER
Identifier Source: secondary_id
DS1001-A-J201
Identifier Type: -
Identifier Source: org_study_id
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