A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04458272|
Recruitment Status : Active, not recruiting
First Posted : July 7, 2020
Last Update Posted : March 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|WHO Grade II Glioma||Drug: DS-1001b||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||July 8, 2020|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2026|
250 mg, twice daily, continuous oral administration
- Overall response rate (ORR) assessed by Independent Efficacy Review Committee [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- 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) ]
- Clinical benefit rate [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- Percentage change in tumor volume [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- Time to response [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- Duration of response [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- Time to treatment failure [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- Progression-free survival [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- Overall survival [ Time Frame: Through the end of the study (up to approximately 6 years) ]
- 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) ]
- Maximum plasma concentration (Cmax) for DS-1001a [ Time Frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) ]
- 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) ]
- 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) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458272
|Nagoya University Hospital|
|Nagoya, Aichi, Japan|
|Kitasato University Hospital|
|Sagamihara, Kanagawa, Japan|
|Tohoku University Hospital|
|Sendai, Miyagi, Japan|
|Saitama Medical University International Medical Center|
|Hidaka, Saitama, Japan|
|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|
|Study Director:||Clinical Study Leader||Daiichi Sankyo, Inc.|
|Responsible Party:||Daiichi Sankyo Co., Ltd.|
|Other Study ID Numbers:||
205339 ( Other Identifier: JapicCTI )
|First Posted:||July 7, 2020 Key Record Dates|
|Last Update Posted:||March 2, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|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/|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|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.|
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
WHO grade II glioma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue