A Phase II study of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma
A Phase II study of DS-1001b in Patients with IDH1 mutated WHO grade II glioma
DAIICHI SANKYO Co.,Ltd.
dsclinicaltrial@daiichisankyo.co.jp
DAIICHI SANKYO Co.,Ltd.
dsclinicaltrial@daiichisankyo.co.jp
completed
July. 08, 2020
25
Interventional
Multicenter, Open-label, Single-arm, Phase II study
treatment purpose
2
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
20age old over
No limit
Both
glioma
investigational material(s)
Generic name etc : DS-1001b
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 250 mg bid, oral administration
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
efficacy
safety
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Number of participants with treatment-emergent adverse events (TEAEs) during the study
pharmacokinetics
pharmacodynamics
efficacy
1) Clinical benefit rate
2) Percentage change in tumor volume
3) Time to response
4) Duration of response
5) Time to treatment failure
6) Progression-free survival
7) Overall survival
8) Pharmacokinetic (PK) profile including AUC, Cmax, Tmax of DS-1001a
9) 2-hydroxyglutarate concentration
Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group.
DAIICHI SANKYO Co.,Ltd.
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Nagoya University Hospital Institutional Review Board
