Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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
Quick Facts
Study Start:2024-02-08
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
Southern Cancer Center
Daphne, Alabama, 36526
United States
The Oncology Institute of Hope and Innovation
Long Beach, California, 90805
United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
United States
Georgetown Lombardi Cancer Center
Washington, District of Columbia, 20057
United States
The Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, 33316
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Illinois Cancer Specialists
Niles, Illinois, 60714
United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Minnesota Oncology Hematology
Burnsville, Minnesota, 55337
United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45226
United States
University Hospital - Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Zangmeister Cancer Center
Columbus, Ohio, 43219
United States
Oncology Associates of Oregon
Eugene, Oregon, 97401
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Oncology & Hematology Associates of Southwest Virginia
Blacksburg, Virginia, 24073
United States
Universtity of Virginia Health System
Charlottesville, Virginia, 22908
United States
Virginia Cancer Specialists Research Institute
Fairfax, Virginia, 22031
United States
Northwest Cancer Specialists
Vancouver, Washington, 98686
United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449
United States
Collaborators and Investigators
Sponsor: Puma Biotechnology, Inc.
- Chief Scientific Officer, STUDY_DIRECTOR, Puma Biotechnology, Inc.
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2024-02-08
Study Completion Date2026-01-31
Study Record Updates
Study Start Date2024-02-08
Study Completion Date2026-01-31
Terms related to this study
Keywords Provided by Researchers
Additional Relevant MeSH Terms