Recruitment Complete
Sponsor ID
20160323
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
Study Details
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Protocol Summary
Primary Outcome Measures
Number of participants with dose limiting toxicities (DLT) for all indications
Timeframe: 6 months
Number of participants with treatment-emergent adverse events (AEs) for all indications
Timeframe: 4 years
Number of participants with treatment-related AEs for all indications
Timeframe: 4 years
Number of participants with clinically significant changes in vital signs for all indications
Timeframe: 4 years
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Timeframe: 4 years
Number of participants with significant changes in physical examinations for all indications
Timeframe: 4 years
Number of participants with significant changes in clinical laboratory tests for all indications
Timeframe: 4 years
Secondary Outcome Measures
Maximum observed concentration (Cmax) following intravenous administration for all indications
Timeframe: 4 years
Minimum observed concentration (Cmin) following intravenous administration for all indications
Timeframe: 4 years
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Timeframe: 4 years
Accumulation following multiple dosing for all indications
Timeframe: 4 years
Half-life (t1/2) following intravenous administration for all indications
Timeframe: 4 years
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeframe: 4 years
Duration of Response (DOR) for all indications
Timeframe: 4 years
Time to Response (TTR)
Timeframe: 4 years
9-month Progression-Free Survival (PFS) for all indications
Timeframe: 9 months
9-month Overall Survival (OS) for all indications
Timeframe: 9 months
Locations
Location
Fox Chase Cancer Center
Philadelphia, PA, United States, 19111
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Completed
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
Location
Gustave Roussy
Villejuif, France, 94805
Status
Recruiting
Location
Sarah Cannon Research Institute
Nashville, TN, United States, 37203
Status
Recruiting
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