GliomaPhase 1NCT03030066

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

A Phase 1 study testing DS-1001b in people with Glioma, run by Daiichi Sankyo at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glioma
What is being tested?: DS-1001b
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteJapan
Study dates: 19 Jan 2017to 16 Jul 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

National Cancer Center Hospital
Tokyo

Other trials in Japan

About this study

Official title: A Phase 1 Study of DS-1001b in Patients With 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.

Conditions: Glioma
Being tested: DS-1001b
Keywords: DS-1001b, IDH1 mutation, Developmental Phase I, Glioma
Medical subject headings: Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DS-1001bDrug
Also called Investigational
Generic not assigned

Study groups in NCT03030066
Study group	Role	What they receive
Experimental Drug DS-1001b	Experimental	Oral administration Receives: Drug: DS-1001b

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of participants with dose limiting toxicities
Measured: 21 days

Secondary outcomes (6)

Percentage of participants experiencing an adverse event (AE)
AEs temporally associated with DS-1001b treatment
Measured: up to 36 months
Area under the concentration curve (AUC) for DS-1001b
Measured: up to 36 months
Maximum plasma concentration (Cmax) for DS-1001b
Measured: up to 36 months
Time to maximum plasma concentration (Tmax) for DS-1001b
Measured: up to 36 months
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Measured: Baseline, up to 36 months
Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)
Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 201716 Jul 2026

First posted24 Jan 2017 (estimated)
Study start19 Jan 2017
Primary completion31 Jan 2021
Study completion16 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GliomaStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03030066
Sponsor's protocol ID: DS1001-A-J101
Other IDs: 163479
Status last verified: Jul 2026
First submitted: 18 Jan 2017
Last updated: 28 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

All Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas
ClinicalTrials.gov ID: NCT03030066
Acronym / sponsor ID: DS1001-A-J101
Conditions: Glioma
Keywords: DS-1001b, IDH1 mutation, Developmental Phase I, Glioma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: 19 Jan 2017 (actual)
Primary completion: 31 Jan 2021 (actual)
Study completion: 16 Jul 2026 (actual)
First posted: 24 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental Drug DS-1001b	Experimental	Drug: DS-1001bOral administration

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DS-1001bAlso: InvestigationalGeneric not assigned	Drug	Experimental Drug DS-1001b

Primary outcome

Percentage of participants with dose limiting toxicities
Time frame: 21 days

6 secondary outcomes

Percentage of participants experiencing an adverse event (AE)
Time frame: up to 36 months
Area under the concentration curve (AUC) for DS-1001b
Time frame: up to 36 months
Maximum plasma concentration (Cmax) for DS-1001b
Time frame: up to 36 months
Time to maximum plasma concentration (Tmax) for DS-1001b
Time frame: up to 36 months
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Time frame: Baseline, up to 36 months
Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)
Time frame: up to 36 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Glioma

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Daiichi Sankyo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-1001b in people with Glioma, run by Daiichi Sankyo at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with dose limiting toxicities (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03030066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.