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New pill shows promise for untreated brain tumor patients

NCT ID NCT04458272

Disease control Sponsor: Daiichi Sankyo Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called DS-1001b in 25 people with a specific type of slow-growing brain tumor (grade II glioma) that has an IDH1 mutation. Participants have not had chemotherapy or radiation before. The goal is to see if the drug can shrink or control the tumor and to check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

glioma grade II glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Who grade II glioma

Contacts and locations

Locations

  • Hiroshima University Hospital

    Hiroshima, Japan

  • Kitasato University Hospital

    Sagamihara, Kanagawa, Japan

  • Kumamoto University Hospital

    Kumamoto, Japan

  • Kyorin University Hospital

    Tokyo, Japan

  • Kyoto University Hospital

    Kyoto, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, Japan

  • National Cancer Center Hospital

    Tokyo, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, Japan

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, Japan

  • Tokyo Women's Medical University Hospital

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.