Clinical Trials /

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

NCT04458272

Description:

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.

Related Conditions:
  • WHO Grade II Glioma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: DS1001-A-J201
  • SECONDARY ID: 205339
  • NCT ID: NCT04458272

Conditions

  • WHO Grade II Glioma

Interventions

DrugSynonymsArms
DS-1001bDS-1001b

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
DS-1001bExperimental
  • DS-1001b

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Clinical benefit rate
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:
Measure:Percentage change in tumor volume
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:
Measure:Time to response
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:
Measure:Duration of response
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:
Measure:Time to treatment failure
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:
Measure:Progression-free survival
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Through the end of the study (up to approximately 6 years)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Maximum plasma concentration (Cmax) for DS-1001a
Time Frame:Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo Co., Ltd.

Trial Keywords

  • DS-1001
  • IDH1
  • Glioma
  • IDH-mutant glioma
  • WHO grade II glioma
  • Low-grade glioma

Last Updated

July 31, 2020