NCT03030066

Brief Summary

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 Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
4mo left

Started Jan 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2017Aug 2026

First Submitted

Initial submission to the registry

January 18, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

January 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

January 18, 2017

Last Update Submit

February 2, 2026

Conditions

Glioma

Keywords

DS-1001bIDH1 mutationDevelopmental Phase IGlioma

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with dose limiting toxicities

    21 days

Secondary Outcomes (6)

  • Percentage of participants experiencing an adverse event (AE)

    up to 36 months

  • Area under the concentration curve (AUC) for DS-1001b

    up to 36 months

  • Maximum plasma concentration (Cmax) for DS-1001b

    up to 36 months

  • Time to maximum plasma concentration (Tmax) for DS-1001b

    up to 36 months

  • Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b

    Baseline, up to 36 months

  • +1 more secondary outcomes

Study Arms (1)

Experimental Drug DS-1001b

EXPERIMENTAL

Oral administration

Drug: DS-1001b

Interventions

DS-1001bDRUG

Generic not assigned

Also known as: Investigational
Experimental Drug DS-1001b

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has histologically confirmed glioma with an IDH1-R132 mutation
  • Has disease that has recurred or progressed following standard treatment including radiotherapy
  • Has measurable lesion(s) as per RANO criteria
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

You may not qualify if:

  • Has significant symptoms of increased intracranial pressure
  • Has another active neoplasm
  • Has active infection requiring systemic treatment
  • Has a history of severe cardiac disease
  • Has had prior treatment with any inhibitor targeting mutant IDH1
  • Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
  • Is a pregnant or lactating female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 24, 2017

Study Start

January 19, 2017

Primary Completion

January 31, 2021

Study Completion (Estimated)

August 31, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

JP(1)