臨床研究等提出・公開システム

Phase 1 Study of DS-6051b in Japanese Subjects with Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene

Phase 1 study of DS-6051b

Yes

Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Documents: - Study Protocol - Statistical Analysis Plan - Clinical Study Report Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Feb. 10, 2016

Interventional

Multicenter, open-label

treatment purpose

1

- Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

- Previously had or currently has any of the following diseases:
Cardiac failure (NYHA Functional Classification >= Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.
- Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
- Severe or uncontrolled concomitant disease.
- Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.

Both

Advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene

investigational material(s)
Generic name etc : DS-6051b
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Oral administration

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

safety
Safety, tolerability, and pharmacokinetics
- The safety of DS-6051b will be assessed by CTCAE.
- The maximum tolerated dose of DS-6051b, and the recommended dose of DS-6051b for the following clinical studies will be estimated.
- Pharmacokinetics of DS-6051b will be evaluated by following the instruction of the study protocol.

safety
pharmacokinetics
The maximum tolerated dose, the recommended dose of for the following clinical studies, pharmacokinetics, exploratory assessment of tumor response
Tumor response will be assessed by RECIST

Jan. 27, 2016