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

Sponsor

Daiichi Sankyo Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04458272

Collaborator

(none)

Enrollment

Locations

Arm

71.7

Anticipated Duration (Months)

2.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
WHO Grade II Glioma	Drug: DS-1001b	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 8, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DS-1001b	Drug: DS-1001b 250 mg, twice daily, continuous oral administration

Arm

Intervention/Treatment

Experimental: DS-1001b

Drug: DS-1001b

250 mg, twice daily, continuous oral administration

Outcome Measures

Primary Outcome Measures

Overall response rate (ORR) assessed by Independent Efficacy Review Committee [Through the end of the study (up to approximately 6 years)]
Number of participants with treatment-emergent adverse events (TEAEs) during the study [Through the end of the study (up to approximately 6 years)]

Secondary Outcome Measures

Clinical benefit rate [Through the end of the study (up to approximately 6 years)]
Percentage change in tumor volume [Through the end of the study (up to approximately 6 years)]
Time to response [Through the end of the study (up to approximately 6 years)]
Duration of response [Through the end of the study (up to approximately 6 years)]
Time to treatment failure [Through the end of the study (up to approximately 6 years)]
Progression-free survival [Through the end of the study (up to approximately 6 years)]
Overall survival [Through the end of the study (up to approximately 6 years)]
Area under the concentration curve (AUC) for DS-1001a [Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)]
Maximum plasma concentration (Cmax) for DS-1001a [Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)]
Time to maximum plasma concentration (Tmax) for DS-1001a [Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Nagoya University Hospital	Nagoya	Aichi	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
5	Hiroshima University Hospital	Hiroshima		Japan
6	Kumamoto University Hospital	Kumamoto		Japan
7	Kyoto University Hospital	Kyoto		Japan
8	National Hospital Organization Osaka National Hospital	Osaka		Japan
9	Kyorin University Hospital	Tokyo		Japan
10	National Cancer Center Hospital	Tokyo		Japan
11	Tokyo Women's Medical University Hospital	Tokyo		Japan