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

Primary Purpose

Glioma

Status

Active

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

DS-1001b

About this trial

This is an interventional basic science trial for Glioma focused on measuring DS-1001b, IDH1 mutation, Developmental Phase I, Glioma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

National Cancer Center Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Drug DS-1001b

Arm Description

Oral administration

Outcomes

Primary Outcome Measures

Percentage of participants with dose limiting toxicities

Secondary Outcome Measures

Percentage of participants experiencing an adverse event (AE)

AEs temporally associated with DS-1001b treatment

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

Maximum plasma concentration (Cmax) for DS-1001b

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

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

Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)

Full Information

NCT ID

NCT03030066

First Posted

January 18, 2017

Last Updated

March 1, 2023

Sponsor

Daiichi Sankyo Co., Ltd.

Collaborators

Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03030066

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 19, 2017 (Actual)

Primary Completion Date

January 31, 2021 (Actual)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daiichi Sankyo Co., Ltd.

Collaborators

Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Drug DS-1001b

Arm Type

Experimental

Arm Description

Oral administration

Intervention Type

Drug

Intervention Name(s)

DS-1001b

Other Intervention Name(s)

Investigational

Intervention Description

Generic not assigned

Primary Outcome Measure Information:

Title

Percentage of participants with dose limiting toxicities

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Percentage of participants experiencing an adverse event (AE)

Description

AEs temporally associated with DS-1001b treatment

Time Frame

up to 36 months

Title

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

Time Frame

up to 36 months

Title

Maximum plasma concentration (Cmax) for DS-1001b

Time Frame

up to 36 months

Title

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

Time Frame

up to 36 months

Title

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

Time Frame

Baseline, up to 36 months

Title

Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Leader

Organizational Affiliation

Daiichi Sankyo, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

National Cancer Center Hospital

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

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

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