Description:
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients
with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
Title
- Brief Title: A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
- Official Title: A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma
Clinical Trial IDs
- ORG STUDY ID:
DS1001-A-J201
- SECONDARY ID:
205339
- NCT ID:
NCT04458272
Conditions
Interventions
Drug | Synonyms | Arms |
---|
DS-1001b | | DS-1001b |
Purpose
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients
with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
Trial Arms
Name | Type | Description | Interventions |
---|
DS-1001b | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the
2016 WHO classification.
- Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory
conducted during the screening period.
- Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma
except craniotomy or biopsy.
- Has at least 1 measurable and non-enhancing lesion.
- Has an interval of at least 90 days from the latest surgery.
- Has no sign of malignant transformation including the appearance of enhancing lesions
and/or rapid growth of non-enhancing lesions.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
Exclusion Criteria:
- Has had a histopathological diagnosis of WHO grade III or IV glioma.
- Has had a contrast enhancing lesion on brain MRI.
- Has received a prior treatment with any mutant IDH1 inhibitor.
- Has received other investigational products within 28 days before the start of the
study drug treatment.
- Has an active infection requiring systemic treatment.
- Has multiple primary malignancies.
- Has a history of clinically significant cardiac disease.
- Is a pregnant or lactating woman.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate (ORR) assessed by Independent Efficacy Review Committee |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Clinical benefit rate |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Measure: | Percentage change in tumor volume |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Measure: | Time to response |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Measure: | Duration of response |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Measure: | Time to treatment failure |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Measure: | Area under the concentration curve (AUC) for DS-1001a |
Time Frame: | Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Measure: | Maximum plasma concentration (Cmax) for DS-1001a |
Time Frame: | Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Measure: | Time to maximum plasma concentration (Tmax) for DS-1001a |
Time Frame: | Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Measure: | Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b |
Time Frame: | Through the end of the study (up to approximately 6 years) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- DS-1001
- IDH1
- Glioma
- IDH-mutant glioma
- WHO grade II glioma
- Low-grade glioma
Last Updated
February 1, 2021