Spots Global Cancer Trial Database for A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
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Trial Identification
Brief Title: A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Official Title: A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Study ID: NCT06095505
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Southern Cancer Center, Daphne, Alabama, United States
Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States
Georgetown Lombardi Cancer Center, Washington, District of Columbia, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Henry Ford Hospital, Detroit, Michigan, United States
Minnesota Oncology Hematology, Burnsville, Minnesota, 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
SCRI Oncology Partners, Nashville, Tennessee, 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
Contact Details
Name: Chief Scientific Officer
Affiliation: Puma Biotechnology, Inc.
Role: STUDY_DIRECTOR
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