Open Label Study of DS-5573a

Daiichi Sankyo

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Malignant Tumors

Treatments: Drug: DS-5573a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02192567

DS5573-A-J101

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

DS-5573a does escalation (step 1) and expansion (step 2)

Experimental group

Description:

Step 1 of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg Step 2: 30 subjects will be enrolled and treated at the dose determined in Step 1.

Treatment:

Drug: DS-5573a