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

Glioma Clinical Trial

Official title:

A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03030066
• Other study ID #: DS1001-A-J101
• Secondary ID: 163479
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Daiichi Sankyo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: March 1, 2026
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• DS-1001b
Generic not assigned

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with dose limiting toxicities		21 days
Secondary	Percentage of participants experiencing an adverse event (AE)	AEs temporally associated with DS-1001b treatment	up to 36 months
Secondary	Area under the concentration curve (AUC) for DS-1001b		up to 36 months
Secondary	Maximum plasma concentration (Cmax) for DS-1001b		up to 36 months
Secondary	Time to maximum plasma concentration (Tmax) for DS-1001b		up to 36 months
Secondary	Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b		Baseline, up to 36 months
Secondary	Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)		up to 36 months