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NCT Number: NCT04458272

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

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.

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Key information

Conditions

WHO Grade II Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DS-1001b

Drug

250 mg, twice daily, continuous oral administration

Primary outcomes

  1. Overall response rate (ORR) assessed by Independent Efficacy Review Committee

    Time frame: Up to 24 months

  2. Number of participants with treatment-emergent adverse events (TEAEs) during the study

    Time frame: Up to 24 months

Secondary outcomes

  1. Clinical benefit rate

    Time frame: Through the end of the study (up to approximately 6 years)

  2. Percentage change in tumor volume

    Time frame: Through the end of the study (up to approximately 6 years)

  3. Time to response

    Time frame: Through the end of the study (up to approximately 6 years)

  4. Duration of response

    Time frame: Through the end of the study (up to approximately 6 years)

  5. Time to treatment failure

    Time frame: Through the end of the study (up to approximately 6 years)

  6. Progression-free survival

    Time frame: Through the end of the study (up to approximately 6 years)

  7. Overall survival

    Time frame: Through the end of the study (up to approximately 6 years)

  8. Area under the concentration curve (AUC) for DS-1001a

    Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)

  9. Maximum plasma concentration (Cmax) for DS-1001a

    Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)

  10. Time to maximum plasma concentration (Tmax) for DS-1001a

    Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)

  11. Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b

    Time frame: Through the end of the study (up to approximately 6 years)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Jul 7, 2020
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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