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

Daiichi Sankyo

Status and phase: Active, not recruiting; Phase 1

Conditions: Glioma

Treatments: Drug: DS-1001b

Study type: Interventional

Funder types: Industry

Identifiers

NCT03030066

DS1001-A-J101

163479 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Experimental Drug DS-1001b

Experimental group

Description:

Oral administration

Treatment:

Drug: DS-1001b