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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04458272
Other study ID # DS1001-A-J201
Secondary ID 205339
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 8, 2020
Est. completion date June 30, 2026

Study information

Verified date December 2023
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date June 30, 2026
Est. primary completion date March 10, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DS-1001b
250 mg, twice daily, continuous oral administration

Locations

Country Name City State
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 Nagoya University Hospital Nagoya Aichi
Japan National Hospital Organization Osaka National Hospital Osaka
Japan Kitasato University Hospital Sagamihara Kanagawa
Japan Tohoku University Hospital Sendai Miyagi
Japan Kyorin University Hospital Tokyo
Japan National Cancer Center Hospital Tokyo
Japan Tokyo Women's Medical University Hospital Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate (ORR) assessed by Independent Efficacy Review Committee Up to 24 months
Primary Number of participants with treatment-emergent adverse events (TEAEs) during the study Up to 24 months
Secondary Clinical benefit rate Through the end of the study (up to approximately 6 years)
Secondary Percentage change in tumor volume Through the end of the study (up to approximately 6 years)
Secondary Time to response Through the end of the study (up to approximately 6 years)
Secondary Duration of response Through the end of the study (up to approximately 6 years)
Secondary Time to treatment failure Through the end of the study (up to approximately 6 years)
Secondary Progression-free survival Through the end of the study (up to approximately 6 years)
Secondary Overall survival Through the end of the study (up to approximately 6 years)
Secondary Area under the concentration curve (AUC) for DS-1001a Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Secondary Maximum plasma concentration (Cmax) for DS-1001a Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Secondary Time to maximum plasma concentration (Tmax) for DS-1001a Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Secondary Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b Through the end of the study (up to approximately 6 years)
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