Clinical Trials /

Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas

NCT03030066

Description:

This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.

Related Conditions:
  • Glioma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas
  • Official Title: A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas

Clinical Trial IDs

  • ORG STUDY ID: DS1001-A-J101
  • NCT ID: NCT03030066

Conditions

  • Glioma

Interventions

DrugSynonymsArms
DS-1001bInvestigationalExperimental Drug DS-1001b

Purpose

This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.

Trial Arms

NameTypeDescriptionInterventions
Experimental Drug DS-1001bExperimentalOral administration
  • DS-1001b

Eligibility Criteria

        Inclusion Criteria:

          1. Has histologically confirmed glioma with an IDH1-R132 mutation

          2. Has disease that has recurred or progressed following standard treatment including
             radiotherapy

          3. Has measurable lesion(s) as per RANO criteria

          4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

        Exclusion Criteria:

          1. Has significant symptoms of increased intracranial pressure

          2. Has another active neoplasm

          3. Has active infection requiring systemic treatment

          4. Has a history of severe cardiac disease

          5. Has had prior treatment with any inhibitor targeting mutant IDH1

          6. Has had investigational drug treatment within 4 weeks prior to the first dose of study
             treatment

          7. Is a pregnant or lactating female
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of participants with dose limiting toxicities
Time Frame:21 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Percentage of participants experiencing an adverse event (AE)
Time Frame:up to 36 months
Safety Issue:
Description:AEs temporally associated with DS-1001b treatment
Measure:Area under the concentration curve (AUC) for DS-1001b
Time Frame:up to 36 months
Safety Issue:
Description:
Measure:Maximum plasma concentration (Cmax) for DS-1001b
Time Frame:up to 36 months
Safety Issue:
Description:
Measure:Time to maximum plasma concentration (Tmax) for DS-1001b
Time Frame:up to 36 months
Safety Issue:
Description:
Measure:Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
Time Frame:Baseline, up to 36 months
Safety Issue:
Description:
Measure:Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)
Time Frame:up to 36 months
Safety Issue:
Description:

Details

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

Trial Keywords

  • DS-1001b
  • IDH1 mutation
  • Developmental Phase I
  • Glioma

Last Updated