A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
NCT ID: NCT06095505
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-02-08
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alisertib
50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) of alisertib PO BID on days 1-7 of each 21-day cycle
Alisertib
Alisertib enteric-coated tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alisertib
Alisertib enteric-coated tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pathologically confirmed SCLC
* Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Puma Biotechnology, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chief Scientific Officer
Role: STUDY_DIRECTOR
Puma Biotechnology, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Puma Biotechnology, Inc. Clinical Operations Senior Director
Role: CONTACT
Phone: (424) 248-6500
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PUMA-ALI-4201
Identifier Type: -
Identifier Source: org_study_id