Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02004717|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: DS-8895a||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-8895a in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: dose escalation then expansion
Dose escalation of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg. Six dose levels are planned: level 1,0.1 mg/kg; level 2,0.3 mg/kg; level 3, 1.0 mg/kg; level 4,3.0 mg/kg; level 5,10 mg/kg; level 6,20 mg/kg.
Dose Expansion - Up to 20 subjects will be enrolled and treated at the dose determined in Dose Escalation arm.
- number of participants experiencing dose limiting toxicities [ Time Frame: day 1 through day 28 ]to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events
- number of participants experiencing clinical or laboratory adverse events [ Time Frame: from start of treatment to end of treatment, on expected average 12 weeks ]to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events
- serum pharmacokinetics of DS-8895a [ Time Frame: Cycle 1 - days 1, 2, 4, 8 and 15; Cycle 2-days 1, 2, 4, 8 and 15; Cycle 3 and on- days 1; end of study; 45 days post last dose ]pharmacokinetics (Area Under the Curve-AUC, Terminal Elimination half-life-t1/2, Total Body Clearance) of DS-8895a in Japanese subjects with advanced solid tumors, and also to investigate the recommended dose of DS-8895a for subsequent clinical studies
- level of anti-DS-8895a (HAHA) antibody [ Time Frame: Cycle 1 days 1 and 15; Cycle 2 day 1; end of study; 45 days post-last-dose ]Human anti-human antibody (HAHA) profile for DS-8895a [Time Frame: Cycle 1 - days 1, and 15; Cycle 2 and on - days 1; end of study; 45 days post last dose] The presence of HAHA (anti-DS-8895a neutralizing antibody) in serum will be assessed"
- disease control rate [ Time Frame: every 6 weeks ]proportion of subjects with the best overall response of stable disease or better will be measured every 6 weeks until study drug discontinued.
- pharmacodynamic effects in blood [ Time Frame: day 1 and 2 ]effects on blood will be determined at day 1 and 2 of each cycle
- pharmacodynamic effects in tumors [ Time Frame: baseline and day 1 of cycle 2 ]effects on tumor cells will be determined at baseline and day 1 of cycle 2
- objective response rate [ Time Frame: every 6 weeks ]sum of complete response and partial response rates measured every 6 weeks until study drug discontinuation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004717
|National Cancer Center Hospital East|
|Kashiwa, Chiba, Japan, 277-8577|
|Osaka University Hospital|
|Suita, Osaka, Japan, 565-0871|