At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Trebananib 3 mg/kg +2 moredrug
Likely dose
Trebananib 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386) in Adult Japanese Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Trebananib 3 mg/kg, Trebananib 10 mg/kg, and 1 other intervention for Neoplasms, Advanced Solid. Completed, enrolled 18 participants.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profile of trebananib (AMG 386) after intravenous administration in adult Japanese participants with advanced solid tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Advanced Solid
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
Primary CompletionMay 2014
First PostedAug 2015
TodayJul 2026
First PostedAug 17, 2015
Enrollment StartJun 1, 2009
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.9 years ago
Interventions
Trebananib 3 mg/kgdrug
Trebananib (AMG 386) 3 mg/kg, intravenous infusion.
Trebananib 10 mg/kgdrug
Trebananib (AMG 386) 10 mg/kg, intravenous infusion.
Trebananib 30 mg/kgdrug
Trebananib (AMG 386) 30 mg/kg, intravenous infusion.