Sponsor study identifier
interventional
19
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 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.
July 14, 2014
Actual (reported)July 17, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 2017
Actual (reported)January 2017
Actual (reported)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
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
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
Incidence of human anti-human antibodies (HAHA) against DS-5573a
Cycle 1 - Day 1 through Cycle 1 - Day 15.
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 DS-5573a-related biomarkers in blood and tumor
Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Kenji Tamura, MD
National Cancer Center Hospital
19 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2014
First Posted
July 17, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
March 3, 2017
Record last verified: 2017-03
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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