A Phase II study of DS-1001b in Patients with IDH1 mutated WHO grade II glioma
- Conditions
- glioma
- Registration Number
- JPRN-jRCT2080225243
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 25
1.Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification
2.Has confirmed IDH1 mutation at the R132 locus by central laboratory testing.
3.Has no prior anticancer (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy.
4.Has at least 1 measurable and non-enhancing lesion.
5.Has an interval of at least 90 days from the latest surgery.
6.Has no sign of malignant transformation including the appearance of enhancing lesion and/or rapid growth of non-enhancing lesion.
7.Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
1.Has had a histopathological diagnosis of WHO grade III or IV glioma.
2.Has had a contrast enhancing lesion on brain MRI.
3.Has received a prior treatment with any mutant IDH1 inhibitor.
4.Has received other investigational products within 28 days before the start of the study drug treatment.
5.Has multiple primary malignancies.
6.Has an active infection requiring systemic treatment.
7.Has a history of clinically significant cardiac disease.
8.Is a pregnant or lactating woman
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>safety<br>Overall response rate (ORR) assessed by Independent Efficacy Review Committee<br>Number of participants with treatment-emergent adverse events (TEAEs) during the study
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>pharmacodynamics<br>efficacy<br>1)Clinical benefit rate<br>2)Percentage change in tumor volume<br>3)Time to response<br>4)Duration of response<br>5)Time to treatment failure<br>6)Progression-free survival<br>7)Overall survival<br>8)Pharmacokinetic (PK) profile including AUC, Cmax, Tmax of DS-1001a<br>9)2-hydroxyglutarate concentration<br><br>Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group.