Study of DS-1123a in Advanced Solid Tumours

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignant Tumors

Treatments: Drug: DS-1123

Study type: Interventional

Funder types: Industry

Identifiers

NCT02690337

DS1123-A-J101

Details and patient eligibility

About

This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

Enrollment: 27 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, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),

• 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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27 participants in 1 patient group

DS-1123

Experimental group

Description:

This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg.

Treatment:

Drug: DS-1123