Study of DS-1123a in Advanced Solid Tumours

Advanced Solid Malignant Tumors Clinical Trial

Official title:

Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690337
• Other study ID #: DS1123-A-J101
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2017
• Est. primary completion date: November 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, 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.

Related Conditions & MeSH terms

• Advanced Solid Malignant Tumors
• Neoplasms

Intervention

Drug:
• DS-1123
starting intravenous (IV) dose of 0.1 mg/kg.

Locations

Country	Name	City	State
n/a

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	Maximum concentration (Cmax)		Cycles 1, 2 : Days 1,2, 4, 8, 15
Primary	Number and severity of treatment emergent adverse events (TEAEs)		Day 1 to Day 31
Primary	Time of maximum concentration (Tmax)		Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	Elimination rate constant (Kel)		Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	area under the curve AUClast	pharmacokinetics profile	Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	Area under the curve (AUCtau)		Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	Area under the curve (AUCinf)		Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	Half-life (T1/2)		Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	Drug clearance (CL)		Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	Volume of distribution (Vz)		Cycles 1, 2: Days 1,2, 4, 8, 15
Primary	Mean residence time (MRTinf)		Cycles 1, 2: Days 1,2, 4, 8, 15
Secondary	DS-1123a antibody	DS-1123a antibody on Cycle 1: Days 1,15; Cycles 2 and on: Day 1, Stop date, final follow-up date	Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date
Secondary	Change in Cytokines expression	Change in DS-1123a biomarkers Cytokines expression on Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2	Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2