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

Plain-language summary

This study examines the drug DS-1001b in patients with glioma (a type of brain tumor) that carries an IDH1-R132 gene mutation. It enrolled patients with histologically confirmed glioma whose disease had recurred or progressed after standard treatment including radiotherapy. The study is in Phase 1; it is not currently recruiting but is still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Daiichi Sankyo

Intervention

DS-1001b

Start date

1/19/2017

Estimated completion

8/31/2026

Countries

Japan

Related genes

Locations

• Tokyo, Japan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

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

Exclusion Criteria:

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