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

WHO Grade II Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04458272
• Other study ID #: DS1001-A-J201
• Secondary ID: 205339
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 8, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: June 30, 2026
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• WHO Grade II Glioma

Intervention

Drug:
• DS-1001b
250 mg, twice daily, continuous oral administration

Locations

Country	Name	City	State
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Kyorin University Hospital	Tokyo
Japan	National Cancer Center Hospital	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR) assessed by Independent Efficacy Review Committee		Up to 24 months
Primary	Number of participants with treatment-emergent adverse events (TEAEs) during the study		Up to 24 months
Secondary	Clinical benefit rate		Through the end of the study (up to approximately 6 years)
Secondary	Percentage change in tumor volume		Through the end of the study (up to approximately 6 years)
Secondary	Time to response		Through the end of the study (up to approximately 6 years)
Secondary	Duration of response		Through the end of the study (up to approximately 6 years)
Secondary	Time to treatment failure		Through the end of the study (up to approximately 6 years)
Secondary	Progression-free survival		Through the end of the study (up to approximately 6 years)
Secondary	Overall survival		Through the end of the study (up to approximately 6 years)
Secondary	Area under the concentration curve (AUC) for DS-1001a		Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Secondary	Maximum plasma concentration (Cmax) for DS-1001a		Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Secondary	Time to maximum plasma concentration (Tmax) for DS-1001a		Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Secondary	Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b		Through the end of the study (up to approximately 6 years)