Active — Not RecruitingPhase 1

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

Japan47 participantsStarted 2017-01-19

Plain-language 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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of participants with dose limiting toxicities

Timeframe: 21 days

Trial details

NCT IDNCT03030066

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-31

View on ClinicalTrials.gov More Glioma trials