臨床研究等提出・公開システム

A Phease1, Multicenter, Open-Label, Single Sequence Crossover Study to Evaluate Drug-Drug Interaction Potential of OATP1B/CYP3A Inhibitor on The Pharmacokinetics of DS-8201a in Subjects with HER2-Expressing Advanced Solid Malignant Tumors

Phase 1 study of DS-8201a in subject with Advanced Solid Malignant Tumors

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

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

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

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

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

completed

Jan. 24, 2018

Interventional

multi center, open-label

treatment purpose

1

1.Has a pathologically documented unresectable or metastatic solid malignant tumors with HER2 expression (determined by immunohistochemistry [IHC]/in situ hybridization [ISH] [IHC 3+, IHC 2+, IHC 1+, and/or ISH +], Next Generation Sequencing, or other analysis techniques as appropriate) that is refractory to or intolerable with at least 1 prior systemic chemotherapy regimen, or for which no standard treatment is available.
2. LVEF >= 50% .
3. Has an ECOG PS 0 or 1.

1. Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information.
2. Has a medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure.
3. Has complications of ventricular arrhythmia

Both

Advanced Solid Malignant Tumors

investigational material(s)
Generic name etc : DS-8201a
INN of investigational material : trastuzumab deruxtecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : IV solution (Once every 3 weeks, 5.4 mg/kg)

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

pharmacokinetics
- PK parameters of DS-8201a and MAAA-1181a (with/without ritonavir)
- PK parameters of DS-8201a and MAAA-1181a (with/without itraconazole)

- PK parameters (Cmax and AUC0-17d) of DS-8201a and MAAA-1181a (with/without ritonavir)
- PK parameters (Cmax and AUC0-17d) of DS-8201a and MAAA-1181a (with/without itraconazole)

safety
efficacy
pharmacogenomics
- Serious adverse events (SAEs)
- Treatment emergent adverse event
- Discontinuation due to AE
- Discontinuation due to adverse events of special interest (AESIs)
- Physical examination findings (including Eastern Cooperative Oncology Group Performance Status [ECOG PS])
- Vital sign measurements
- Standard clinical laboratory parameters
- 12-lead ECG parameters
- ECHO or MUGA findings
- Ophthalmologic findings
- Anti-drug antibodies

Follow the Clinical Study Protocol

+81-53-435-2850

Dec. 14, 2017