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

NCT ID: NCT03030066

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-19

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Experimental Drug DS-1001b

Oral administration

Group Type EXPERIMENTAL

DS-1001b

Intervention Type DRUG

Generic not assigned

Interventions

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DS-1001b

Generic not assigned

Intervention Type DRUG

Other Intervention Names

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Investigational

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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National Cancer Center Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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163479

Identifier Type: REGISTRY

Identifier Source: secondary_id

DS1001-A-J101

Identifier Type: -

Identifier Source: org_study_id

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