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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
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 8, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Overall response rate (ORR) assessed by Independent Efficacy Review Committee [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  2. 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 Measures :
  1. Clinical benefit rate [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  2. Percentage change in tumor volume [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  3. Time to response [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  4. Duration of response [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  5. Time to treatment failure [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  6. Progression-free survival [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  7. Overall survival [ Time Frame: Through the end of the study (up to approximately 6 years) ]
  8. 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) ]
  9. Maximum plasma concentration (Cmax) for DS-1001a [ Time Frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) ]
  10. 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) ]
  11. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Japan
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
Hiroshima, Japan
Kumamoto University Hospital
Kumamoto, Japan
Kyoto University Hospital
Kyoto, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Kyorin University Hospital
Tokyo, Japan
National Cancer Center Hospital
Tokyo, Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT04458272    
Other Study ID Numbers: DS1001-A-J201
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/
Supporting Materials: Study Protocol
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.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
DS-1001
IDH1
Glioma
IDH-mutant glioma
WHO grade II glioma
Low-grade glioma
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue