Advanced Solid Malignant Tumors
Conditions
Keywords
Advanced solid tumor, DS-6051b, ROS1, NTRK, refractory to standard therapy, no standard therapy
Brief summary
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.
Detailed description
This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) and preliminary efficacy of DS-6051b will be evaluated.
Interventions
DRUGDS-6051b
Drug: DS-6051b 400 mg or 800 mg daily
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number and severity of adverse events | Day 1 through 28 days after last dose | number and severity of treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of DS-6051a | Days 1 and 15 of Cycle 1 | Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1. |
| Tmax of DS-6051a | Days 1 and 15 of Cycle 1 | Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1. |
| AUC of DS-6051a | Days 1 and 15 of Cycle 1 | Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1. |
| clearance (CL/F) of DS-6051a | Days 1 and 15 of Cycle 1 | Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1. |
| Number of participants with dose-limiting toxicities | 21 days following the first dose of treatment | to determine maximum tolerated dose/recommended phase 2 dose |
Countries
Japan
Outcome results
None listed