Open Label Study of DS-5573a

Advanced Solid Malignant Tumors Clinical Trial

Official title:

Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02192567
• Other study ID #: DS5573-A-J101
• Status: Terminated
• Phase: Phase 1
• First received: July 14, 2014
• Last updated: March 1, 2017
• Start date: September 2014
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Malignant Tumors
• Neoplasms

Intervention

Drug:
• DS-5573a
Step 1 of this study will use 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 use the dose determined in Step 1.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing dose limiting toxicities	Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.	Day 1 through Day 28
Primary	Number of subjects experiencing adverse events	Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.	Day 1 through 45 days after last dose
Primary	Pharmacokinetic profile of DS-5573a	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.	Cycle 1 - Day 1 through Cycle 8 - Day 1
Secondary	Incidence of human anti-human antibodies (HAHA) against DS-5573a	Incidence of human anti-human antibodies (HAHA) against DS-5573a.	Cycle 1 - Day 1 through Cycle 1 - Day 15.
Secondary	Assessment of tumor response to DS-5573a using RECIST ver1.1.	Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.	week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90
Secondary	Assessment of DS-5573a-related biomarkers in blood and tumor	Assessment of DS-5573a-related biomarkers in blood and tumor.	Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2