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A Phase 1 Study of DS-1001b in Patients with IDH1 Mutated Gliomas

A Phase 1 Study of DS-1001b in Patients with IDH1 Mutated Gliomas

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial_jp@daiichisankyo.com

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial_jp@daiichisankyo.com

completed

Jan. 19, 2017

Interventional

Multicenter, non-randomized, open-label

treatment purpose

1

1) Subjects must have histologically confirmed glioma with an IDH1-R132 mutation.
2) Subjects must have disease that has recurred or progressed following standard treatment including radiation therapy.
3) Subjects must have measurable lesion(s) as per RANO criteria.
4) Subjects must have ECOG PS of 0 to 2.

1) Subjects with significant symptoms of increased intracranial pressure.
2) Subjects who have active another neoplasm.
3) Subjects with active infection requiring systemic treatment.
4) Subjects with a history of severe cardiac disease
5) Subjects who have received prior treatment with any therapy targeting mutant IDH1.
6) Subjects who have received other investigational drug treatment within 3 weeks prior to the first dose of study treatment.
7) Female subjects who are pregnant or breast feeding.

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 : Oral

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

other
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of DS-1001b

safety
efficacy
pharmacokinetics
pharmacodynamics
1) To assess the safety and tolerability of DS-1001b
2) To characterize the pharmacokinetic (PK) profile of DS-1001b
3) To characterize the pharmacodynamic (PDy) effect of DS-1001b on 2-HG levels
4) To assess the preliminary anti-tumor activity of DS-1001b

Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group.

Dec. 21, 2016