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Completed

NCT Number: NCT03030066

Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas

This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.

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Key information

Conditions

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 1

Primary location

National Cancer Center Hospital

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has histologically confirmed glioma with an IDH1-R132 mutation
  • Has disease that has recurred or progressed following standard treatment including radiotherapy
  • Has measurable lesion(s) as per RANO criteria
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion criteria

  • Has significant symptoms of increased intracranial pressure
  • Has another active neoplasm
  • Has active infection requiring systemic treatment
  • Has a history of severe cardiac disease
  • Has had prior treatment with any inhibitor targeting mutant IDH1
  • Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
  • Is a pregnant or lactating female

Treatment and study plan

DS-1001b

Drug

Generic not assigned

Other names: Investigational

Primary outcomes

  1. Percentage of participants with dose limiting toxicities

    Time frame: 21 days

Secondary outcomes

  1. Percentage of participants experiencing an adverse event (AE)

    Time frame: up to 36 months

    AEs temporally associated with DS-1001b treatment

  2. Area under the concentration curve (AUC) for DS-1001b

    Time frame: up to 36 months

  3. Maximum plasma concentration (Cmax) for DS-1001b

    Time frame: up to 36 months

  4. Time to maximum plasma concentration (Tmax) for DS-1001b

    Time frame: up to 36 months

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

    Time frame: Baseline, up to 36 months

  6. Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)

    Time frame: up to 36 months

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas

Important dates

Study start
2017
Primary completion
2021
Study completion
2026
First posted
Jan 24, 2017
Registry last updated
Jul 28, 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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