Back to resultsA Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
Primary Purpose
WHO Grade II Glioma
Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
DS-1001b
Sponsored by
About this trial
This is an interventional treatment trial for WHO Grade II Glioma focused on measuring DS-1001, IDH1, Glioma, IDH-mutant glioma, WHO grade II glioma, Low-grade glioma
Eligibility Criteria
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.
Sites / Locations
- Nagoya University Hospital
- Kitasato University Hospital
- Tohoku University Hospital
- Saitama Medical University International Medical Center
- Hiroshima University Hospital
- Kumamoto University Hospital
- Kyoto University Hospital
- National Hospital Organization Osaka National Hospital
- Kyorin University Hospital
- National Cancer Center Hospital
- Tokyo Women's Medical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DS-1001b
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Number of participants with treatment-emergent adverse events (TEAEs) during the study
Secondary Outcome Measures
Clinical benefit rate
Percentage change in tumor volume
Time to response
Duration of response
Time to treatment failure
Progression-free survival
Overall survival
Area under the concentration curve (AUC) for DS-1001a
Maximum plasma concentration (Cmax) for DS-1001a
Time to maximum plasma concentration (Tmax) for DS-1001a
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04458272
Brief Title
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
Official Title
A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
WHO Grade II Glioma
Keywords
DS-1001, IDH1, Glioma, IDH-mutant glioma, WHO grade II glioma, Low-grade glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DS-1001b
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DS-1001b
Intervention Description
250 mg, twice daily, continuous oral administration
Primary Outcome Measure Information:
Title
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Number of participants with treatment-emergent adverse events (TEAEs) during the study
Time Frame
Through the end of the study (up to approximately 6 years)
Secondary Outcome Measure Information:
Title
Clinical benefit rate
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Percentage change in tumor volume
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Time to response
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Duration of response
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Time to treatment failure
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Progression-free survival
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Overall survival
Time Frame
Through the end of the study (up to approximately 6 years)
Title
Area under the concentration curve (AUC) for DS-1001a
Time Frame
Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Title
Maximum plasma concentration (Cmax) for DS-1001a
Time Frame
Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Title
Time to maximum plasma concentration (Tmax) for DS-1001a
Time Frame
Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Title
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Time Frame
Through the end of the study (up to approximately 6 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
State/Province
Saitama
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
Country
Japan
Facility Name
Kyorin University Hospital
City
Tokyo
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
35722822
Citation
Natsume A, Arakawa Y, Narita Y, Sugiyama K, Hata N, Muragaki Y, Shinojima N, Kumabe T, Saito R, Motomura K, Mineharu Y, Miyakita Y, Yamasaki F, Matsushita Y, Ichimura K, Ito K, Tachibana M, Kakurai Y, Okamoto N, Asahi T, Nishijima S, Yamaguchi T, Tsubouchi H, Nakamura H, Nishikawa R. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol. 2023 Feb 14;25(2):326-336. doi: 10.1093/neuonc/noac155.
Results Reference
derived
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A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
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