A Phase 2 interventional study of DS-1001b in WHO Grade II Glioma, sponsored by Daiichi Sankyo Co., Ltd.. Active, not recruiting at 11 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Daiichi Sankyo Co., Ltd. · Phase 2, Interventional, and Treatment
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.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
This study's planned enrollment of 25 is below the median of 32 across 1,075 interventional studies indexed under Glioma.
Browse Glioma studies →Daiichi Sankyo Co., Ltd. is the lead sponsor of 73 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: DS-1001b
250 mg, twice daily, continuous oral administration
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
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)
Plan to share: 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/
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
Ran from Jul 2020 to primary completion in Mar 2023, 32 months.
Of 131 phase 2 interventional studies under Glioma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 88. This study's 32 months is below that.
Completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Feb 2027, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Safusidenib