NCT04458272

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
4mo left

Started Jul 2020

Longer than P75 for phase_2

Geographic Reach
1 country

11 active sites

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 Progress95%
Jul 2020Aug 2026

First Submitted

Initial submission to the registry

June 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

June 29, 2020

Last Update Submit

March 17, 2026

Conditions

WHO Grade II Glioma

Keywords

DS-1001IDH1GliomaIDH-mutant gliomaWHO grade II gliomaLow-grade glioma

Outcome Measures

Primary Outcomes (2)

  • Overall response rate (ORR) assessed by Independent Efficacy Review Committee

    Up to 24 months

  • Number of participants with treatment-emergent adverse events (TEAEs) during the study

    Up to 24 months

Secondary Outcomes (11)

  • Clinical benefit rate

    Through the end of the study (up to approximately 6 years)

  • Percentage change in tumor volume

    Through the end of the study (up to approximately 6 years)

  • Time to response

    Through the end of the study (up to approximately 6 years)

  • Duration of response

    Through the end of the study (up to approximately 6 years)

  • Time to treatment failure

    Through the end of the study (up to approximately 6 years)

  • +6 more secondary outcomes

Study Arms (1)

DS-1001b

EXPERIMENTAL
Drug: DS-1001b

Interventions

DS-1001bDRUG

250 mg, twice daily, continuous oral administration

DS-1001b

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Location

Hiroshima University Hospital

Hiroshima, Japan

Location

Kumamoto University Hospital

Kumamoto, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Japan

Location

Kyorin University Hospital

Tokyo, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, Japan

Location

Related Publications (2)

  • Arakawa Y, Saito R, Kanemura Y, Mishima K, Koriyama S, Narita Y, Kumabe T, Motomura K, Sugiyama K, Yamasaki F, Mukasa A, Kanamori M, Kuga D, Nagane M, Kakurai Y, Isobe K, Nakamura H. Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naive isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas. Neuro Oncol. 2025 Nov 8:noaf258. doi: 10.1093/neuonc/noaf258. Online ahead of print.

    PMID: 41206766DERIVED

  • Natsume A, Arakawa Y, Narita Y, Sugiyama K, Hata N, Muragaki Y, Shinojima N, Kumabe T, Saito R, Motomura K, Mineharu Y, Miyakita Y, Yamasaki F, Matsushita Y, Ichimura K, Ito K, Tachibana M, Kakurai Y, Okamoto N, Asahi T, Nishijima S, Yamaguchi T, Tsubouchi H, Nakamura H, Nishikawa R. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol. 2023 Feb 14;25(2):326-336. doi: 10.1093/neuonc/noac155.

    PMID: 35722822DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Study Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 7, 2020

Study Start

July 8, 2020

Primary Completion

March 10, 2023

Study Completion (Estimated)

August 31, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

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(11)