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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    25
  • sponsor
    Daiichi Sankyo Co., Ltd.
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Updated on 19 February 2024
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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.

Details
Condition WHO Grade II Glioma
Age 20-100 years
Treatment DS-1001b
Clinical Study IdentifierNCT04458272
SponsorDaiichi Sankyo Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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