WHO Grade II GliomaPhase 2NCT04458272
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
A Phase 2 study testing DS-1001b in people with WHO Grade II Glioma, run by Daiichi Sankyo Co., Ltd. at 11 sites in Japan.
Trial summary
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- WHO Grade II 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
- 25 participants
- Where
- 11 sitesJapan
- Study dates
- 8 Jul 2020to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Saitama Medical University International Medical Center
Hidaka, Saitama
Hiroshima University Hospital
Hiroshima
Kumamoto University Hospital
Kumamoto
Kyoto University Hospital
Kyoto
Nagoya University Hospital
Nagoya, Aichi-ken
National Hospital Organization Osaka National Hospital
Osaka
Kitasato University Hospital
Sagamihara, Kanagawa
Tohoku University Hospital
Sendai, Miyagi
Kyorin University Hospital
Tokyo
National Cancer Center Hospital
Tokyo
Tokyo Women's Medical University Hospital
Tokyo
About this study
Official title: A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
- Conditions
- WHO Grade II Glioma
- Being tested
- DS-1001b
- Keywords
- DS-1001, IDH1, Glioma, IDH-mutant glioma, WHO grade II glioma, Low-grade 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
250 mg, twice daily, continuous oral administration
| Study group | Role | What they receive |
|---|---|---|
| DS-1001b | Experimental | Not described Receives: Drug: DS-1001b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Measured: Up to 24 months
Number of participants with treatment-emergent adverse events (TEAEs) during the study
Measured: Up to 24 months
Secondary outcomes (11)
Clinical benefit rate
Measured: Through the end of the study (up to approximately 6 years)
Percentage change in tumor volume
Measured: Through the end of the study (up to approximately 6 years)
Time to response
Measured: Through the end of the study (up to approximately 6 years)
Duration of response
Measured: Through the end of the study (up to approximately 6 years)
Time to treatment failure
Measured: Through the end of the study (up to approximately 6 years)
Progression-free survival
Measured: Through the end of the study (up to approximately 6 years)
Overall survival
Measured: Through the end of the study (up to approximately 6 years)
Area under the concentration curve (AUC) for DS-1001a
Measured: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Maximum plasma concentration (Cmax) for DS-1001a
Measured: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) for DS-1001a
Measured: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Measured: Through the end of the study (up to approximately 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start8 Jul 2020
- Primary completion10 Mar 2023
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WHO Grade II GliomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458272
- Sponsor's protocol ID
- DS1001-A-J201
- Other IDs
- 205339
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2020
- Last updated
- 6 Oct 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/
Publications
Arakawa Y, Saito R, Kanemura Y, Mishima K, Koriyama S, Narita Y, Kumabe T, Motomura K, Sugiyama K, Yamasaki F, Mukasa A, Kanamori M, Kuga D, Nagane M, Kakurai Y, Isobe K, Nakamura H. Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naive isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas. Neuro Oncol. 2026 Mar 1;28(3):717-727. doi: 10.1093/neuonc/noaf258.
PubMed 41206766Natsume A, Arakawa Y, Narita Y, Sugiyama K, Hata N, Muragaki Y, Shinojima N, Kumabe T, Saito R, Motomura K, Mineharu Y, Miyakita Y, Yamasaki F, Matsushita Y, Ichimura K, Ito K, Tachibana M, Kakurai Y, Okamoto N, Asahi T, Nishijima S, Yamaguchi T, Tsubouchi H, Nakamura H, Nishikawa R. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol. 2023 Feb 14;25(2):326-336. doi: 10.1093/neuonc/noac155.
PubMed 35722822
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma
- ClinicalTrials.gov ID
- NCT04458272
- Acronym / sponsor ID
- DS1001-A-J201
- Conditions
- WHO Grade II Glioma
- Keywords
- DS-1001, IDH1, Glioma, IDH-mutant glioma, WHO grade II glioma, Low-grade glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 7 Jul 2020 (actual)
- 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 Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS-1001b | Experimental | Drug: DS-1001b |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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-1001b250 mg, twice daily, continuous oral administration | Drug | DS-1001b |
Primary outcome
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Time frame: Up to 24 months
Number of participants with treatment-emergent adverse events (TEAEs) during the study
Time frame: Up to 24 months
11 secondary outcomes
Clinical benefit rate
Time frame: Through the end of the study (up to approximately 6 years)
Percentage change in tumor volume
Time frame: Through the end of the study (up to approximately 6 years)
Time to response
Time frame: Through the end of the study (up to approximately 6 years)
Duration of response
Time frame: Through the end of the study (up to approximately 6 years)
Time to treatment failure
Time frame: Through the end of the study (up to approximately 6 years)
Progression-free survival
Time frame: Through the end of the study (up to approximately 6 years)
Overall survival
Time frame: Through the end of the study (up to approximately 6 years)
Area under the concentration curve (AUC) for DS-1001a
Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Maximum plasma concentration (Cmax) for DS-1001a
Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) for DS-1001a
Time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Time frame: Through the end of the study (up to approximately 6 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Derived from this study: PubMed 41206766Arakawa Y, Saito R, Kanemura Y, Mishima K, Koriyama S, Narita Y, Kumabe T, Motomura K, Sugiyama K, Yamasaki F, Mukasa A, Kanamori M, Kuga D, Nagane M, Kakurai Y, Isobe K, Nakamura H. Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naive isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas. Neuro Oncol. 2026 Mar 1;28(3):717-727. doi: 10.1093/neuonc/noaf258.
- Derived from this study: PubMed 35722822Natsume A, Arakawa Y, Narita Y, Sugiyama K, Hata N, Muragaki Y, Shinojima N, Kumabe T, Saito R, Motomura K, Mineharu Y, Miyakita Y, Yamasaki F, Matsushita Y, Ichimura K, Ito K, Tachibana M, Kakurai Y, Okamoto N, Asahi T, Nishijima S, Yamaguchi T, Tsubouchi H, Nakamura H, Nishikawa R. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol. 2023 Feb 14;25(2):326-336. doi: 10.1093/neuonc/noac155.
- 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/
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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.
Clinical Study Leader study director
Daiichi Sankyo
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS-1001b in people with WHO Grade II Glioma, run by Daiichi Sankyo Co., Ltd. at 11 sites 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Overall response rate (ORR) assessed by Independent Efficacy Review Committee (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 NCT04458272, which also lists 2 linked publications.
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 6 Oct 2026.