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

Not Applicable

Active, not recruiting

• Conditions: Glioma
• Interventions: Drug: DS-1001b

• Registration Number: NCT03030066
• Lead Sponsor: Daiichi Sankyo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-18
• Study Start: 2017-01-19
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Primary Completion: 2021-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Drug DS-1001b	DS-1001b	Oral administration

Primary Outcome Measures

Name	Time	Method
Percentage of participants with dose limiting toxicities	21 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan