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A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Sponsor: Puma Biotechnology, Inc.
Summary
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
Official title: A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-02-08
Completion Date
2027-10-31
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Alisertib
Alisertib enteric-coated tablets
Locations (30)
Southern Cancer Center
Daphne, Alabama, United States
The Oncology Institute of Hope and Innovation
Long Beach, California, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Georgetown Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Clermont Oncology Center
Clermont, Florida, United States
The Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Oncology Hematology
Burnsville, Minnesota, United States
Nebraska Cancer Specialists
Grand Island, Nebraska, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States
University Hospital - Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Oncology & Hematology Associates of Southwest Virginia
Blacksburg, Virginia, United States
Universtity of Virginia Health System
Charlottesville, Virginia, United States
Virginia Cancer Specialists Research Institute
Fairfax, Virginia, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
Marshfield Medical Center
Marshfield, Wisconsin, United States