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A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma

NCT04458272•Daiichi Sankyo Co., Ltd.

View on ClinicalTrials.gov

Summary

This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification.
•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 histopathological diagnosis of WHO grade III or IV glioma.
•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.

Locations (11)

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

Key Dates

Start Date

July 8, 2020

Primary Completion Date

March 10, 2023

Completion Date

August 31, 2026

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

WHO Grade II Glioma

Interventions

DS-1001b

DRUG

BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

NCT03749187

GlioblastomaIDH1 Gene Mutation+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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