Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2022
• Main ID: NCT02675491
• Date of registration: 02/02/2016
• Prospective Registration: No
• Primary sponsor: Daiichi Sankyo Co., Ltd.
• Public title: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
• Scientific title: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
• Date of first enrolment: February 2016
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02675491
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Global Clinical Leader
• Affiliation: Daiichi Sankyo, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Solid Malignant Tumors

Intervention(s)

Drug: DS-6051b

Primary Outcome(s)

number and severity of adverse events [Time Frame: Day 1 through 28 days after last dose]

Secondary Outcome(s)

AUC of DS-6051a [Time Frame: Days 1 and 15 of Cycle 1]

clearance (CL/F) of DS-6051a [Time Frame: Days 1 and 15 of Cycle 1]

Cmax of DS-6051a [Time Frame: Days 1 and 15 of Cycle 1]

Number of participants with dose-limiting toxicities [Time Frame: 21 days following the first dose of treatment]

Tmax of DS-6051a [Time Frame: Days 1 and 15 of Cycle 1]

Secondary ID(s)

153111

DS6051-A-J102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors