Status:
TERMINATED
Open Label Study of DS-5573a
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Advanced Solid Malignant Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.
Eligibility Criteria
Inclusion
- Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
- Eastern Cooperative Oncology Group performance status(PS) of 0 or 1
Exclusion
- Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:
- Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment.
- Severe or uncontrolled concomitant disease.
- Clinically active brain metastases defined as symptomatic or requiring treatment.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02192567
Start Date
September 1 2014
End Date
January 1 2017
Last Update
March 3 2017
Active Locations (1)
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1
National Cancer Center Hospital
Tokyo, Japan, 104-0045