Clinical trial · Interventional
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas
A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas
NCT03030066CI-TRIAL-00119577completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS-1001b | Drug | Safusidenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Drug DS-1001b
- description
- Oral administration
- interventionNames
- Drug: DS-1001b
Primary outcomes (1)
- measure
- Percentage of participants with dose limiting toxicities
- timeFrame
- 21 days
Secondary outcomes (6)
- measure
- Percentage of participants experiencing an adverse event (AE)
- timeFrame
- up to 36 months
- description
- AEs temporally associated with DS-1001b treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.