A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

Daiichi Sankyo

Status and phase

Active, not recruiting

Phase 2

Conditions

WHO Grade II Glioma

Treatments

Drug: DS-1001b

Study type

Interventional

Funder types

Industry

Identifiers

NCT04458272

205339 (Other Identifier)

DS1001-A-J201

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.