Status:
ACTIVE_NOT_RECRUITING
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
WHO Grade II Glioma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04458272
Start Date
July 8 2020
End Date
August 31 2026
Last Update
March 18 2025
Active Locations (11)
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1
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
2
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
3
Tohoku University Hospital
Sendai, Miyagi, Japan
4
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan