Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
DS1001-A-J101
- SECONDARY ID:
163479
- NCT ID:
NCT03030066
Conditions
Interventions
Drug | Synonyms | Arms |
---|
DS-1001b | Investigational | Experimental Drug DS-1001b |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental Drug DS-1001b | Experimental | Oral administration | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of participants with dose limiting toxicities |
Time Frame: | 21 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Percentage of participants experiencing an adverse event (AE) |
Time Frame: | up to 36 months |
Safety Issue: | |
Description: | AEs temporally associated with DS-1001b treatment |
Measure: | Area under the concentration curve (AUC) for DS-1001b |
Time Frame: | up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Maximum plasma concentration (Cmax) for DS-1001b |
Time Frame: | up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Time to maximum plasma concentration (Tmax) for DS-1001b |
Time Frame: | up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b |
Time Frame: | Baseline, up to 36 months |
Safety Issue: | |
Description: | |
Measure: | Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO) |
Time Frame: | up to 36 months |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- DS-1001b
- IDH1 mutation
- Developmental Phase I
- Glioma
Last Updated
March 15, 2021