NCT02690337|CompletedPhase 1
Study of DS-1123a in Advanced Solid Tumours
Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors
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Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors
Sponsor study identifier
interventional
27
1 country
1
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Actual (reported)Study Completion
November 2017
Actual (reported)This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
February 4, 2016
Actual (reported)February 24, 2016
Actual (reported)November 2017
Actual (reported)November 2017
Actual (reported)Maximum concentration (Cmax)
Cycles 1, 2 : Days 1,2, 4, 8, 15
Number and severity of treatment emergent adverse events (TEAEs)
Day 1 to Day 31
Time of maximum concentration (Tmax)
Cycles 1, 2: Days 1,2, 4, 8, 15
Elimination rate constant (Kel)
Cycles 1, 2: Days 1,2, 4, 8, 15
area under the curve AUClast
pharmacokinetics profile
Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCtau)
Cycles 1, 2: Days 1,2, 4, 8, 15
DS-1123a antibody
Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date
Change in Cytokines expression
Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2
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.
starting intravenous (IV) dose of 0.1 mg/kg.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tokyo, 277-8577, Japan
Global Clinical Leader
Daiichi Sankyo
27 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2016
First Posted
February 24, 2016
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Area under the curve (AUCinf)
Cycles 1, 2: Days 1,2, 4, 8, 15
Half-life (T1/2)
Cycles 1, 2: Days 1,2, 4, 8, 15
Drug clearance (CL)
Cycles 1, 2: Days 1,2, 4, 8, 15
Volume of distribution (Vz)
Cycles 1, 2: Days 1,2, 4, 8, 15
Mean residence time (MRTinf)
Cycles 1, 2: Days 1,2, 4, 8, 15
Contact the study team to confirm eligibility.
Primary Completion
November 2017
Actual (reported)Study Completion
November 2017
Actual (reported)Last Updated
December 24, 2018
Record last verified: 2018-01
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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