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

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03030066
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Daiichi Sankyo
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Global Clinical Leader
Principal Investigator Affiliation	Daiichi Sankyo
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Arms & Interventions

Arms

Experimental: Experimental Drug DS-1001b

Oral administration

Interventions

Drug: - DS-1001b

Generic not assigned

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

National Cancer Center Hospital, Tokyo, Japan

Status

Address

National Cancer Center Hospital

Tokyo, ,

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