Open Label Study of DS-5573a

Phase 1

Terminated

• Conditions: Advanced Solid Malignant Tumors
• Interventions: Drug: DS-5573a

• Registration Number: NCT02192567
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Study Start: 2014-09
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DS-5573a does escalation (step 1) and expansion (step 2)	DS-5573a	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing dose limiting toxicities	Day 1 through Day 28	Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.
Number of subjects experiencing adverse events	Day 1 through 45 days after last dose	Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.
Pharmacokinetic profile of DS-5573a	Cycle 1 - Day 1 through Cycle 8 - Day 1	Pharmacokinetic profile of DS-5573a. \[Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1\] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors.

Secondary Outcome Measures

Name	Time	Method
Incidence of human anti-human antibodies (HAHA) against DS-5573a	Cycle 1 - Day 1 through Cycle 1 - Day 15.	Incidence of human anti-human antibodies (HAHA) against DS-5573a.
Assessment of tumor response to DS-5573a using RECIST ver1.1.	week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90	Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.
Assessment of DS-5573a-related biomarkers in blood and tumor	Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2	Assessment of DS-5573a-related biomarkers in blood and tumor.

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan