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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04458272
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Daiichi Sankyo Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Study Leader
Principal Investigator Affiliation	Daiichi Sankyo
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	WHO Grade II Glioma

Arms & Interventions

Arms

Experimental: DS-1001b

Interventions

Drug: - DS-1001b

250 mg, twice daily, continuous oral administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nagoya University Hospital, Nagoya, Aichi, Japan

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Nagoya University Hospital

Nagoya, Aichi,

Kitasato University Hospital, Sagamihara, Kanagawa, Japan

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Kitasato University Hospital

Sagamihara, Kanagawa,

Tohoku University Hospital, Sendai, Miyagi, Japan

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Tohoku University Hospital

Sendai, Miyagi,

Hidaka, Saitama, Japan

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Saitama Medical University International Medical Center

Hidaka, Saitama,

Hiroshima University Hospital, Hiroshima, Japan

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Hiroshima University Hospital

Hiroshima, ,

Kumamoto University Hospital, Kumamoto, Japan

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Kumamoto University Hospital

Kumamoto, ,

Kyoto University Hospital, Kyoto, Japan

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Kyoto University Hospital

Kyoto, ,

Osaka, Japan

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National Hospital Organization Osaka National Hospital

Osaka, ,

Kyorin University Hospital, Tokyo, Japan

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Kyorin University Hospital

Tokyo, ,

National Cancer Center Hospital, Tokyo, Japan

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National Cancer Center Hospital

Tokyo, ,

Tokyo, Japan

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Tokyo Women's Medical University Hospital

Tokyo, ,

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