Study Complete
Sponsor ID
20170533
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
Study Details
Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D])
Protocol Summary
Primary Outcome Measures
Incidence of dose limiting toxicities (DLTs)
Timeframe: up to 2 years
Incidence of treatment-emergent adverse events
Timeframe: up to 2 years
Incidence of treatment-related adverse events
Timeframe: up to 2 years
Incidence of disease-related events
Timeframe: up to 2 years
Incidence of clinically-significant changes in vital signs
Timeframe: up to 2 years
Incidence of clinically-significant changes in physical examinations
Timeframe: up to 2 years
Incidence of clinically-significant changes in electrocardiograms (ECG)s
Timeframe: up to 2 years
Incidence of clinically-significant changes in clinical laboratory tests
Timeframe: up to 2 years
Secondary Outcome Measures
Maximum observed concentration (Cmax) of AMG 562
Timeframe: Day 1, 8, 15, 22
minimum concentration (Cmin)
Timeframe: Day 1, 8, 15, 22
time of maximum concentration (Tmax)
Timeframe: Day 1, 8, 15, 22
area under the concentration-time curve (AUC)
Timeframe: Day 1, 8, 15, 22
Half Life (t1/2)
Timeframe: Day 1, 8, 15, 22
Efficacy-Overall Response
Timeframe: Week 5, 15, 20, 25 and EoT
Efficacy-Objective Response Rate (ORR)
Timeframe: Week 5, 15, 20, 25 and EoT
Efficacy-Duration of Response (DOR)
Timeframe: Week 5, 15, 20, 25 and EoT
Efficacy-Progression Free Survival (PFS)
Timeframe: Week 5, 15, 20, 25 and EoT
Efficacy-Overall Survival (OS)
Timeframe: Week 5, 15, 20, 25 and EoT
Locations
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Completed
Location
University of California Los Angeles
Los Angeles, CA, United States, 90095
Status
Recruiting
Location
Klinikum der Universität München Campus Großhadern
München, Germany, 81377
Status
Completed
Location
Washington University
St Louis, MO, United States, 63110
Status
Recruiting
Location
Princess Margaret Cancer Centre
Toronto, ON, Canada, M5G 2M9
Status
Completed
Location
University of Maryland Greenebaum Cancer Center
Baltimore, MD, United States, 21201
Status
Completed
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