Recruitment Complete
Sponsor ID
20160323

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Sponsor ID
20160323
Clinicaltrials.gov ID
NCT03319940
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
269
Additional Study Details

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
Status
Contact Us
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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