A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged ≥18 years at signing of informed consent
• 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
Locations
United States
Alabama
Southern Cancer Center
RECRUITING
Daphne
California
The Oncology Institute of Hope and Innovation
RECRUITING
Long Beach
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Lone Tree
Washington, D.c.
Georgetown Lombardi Cancer Center
RECRUITING
Washington D.c.
Florida
Clermont Oncology Center
RECRUITING
Clermont
The Oncology Institute of Hope and Innovation
RECRUITING
Fort Lauderdale
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
Illinois Cancer Specialists
RECRUITING
Niles
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Minnesota
Minnesota Oncology Hematology
RECRUITING
Burnsville
Nebraska
Nebraska Cancer Specialists
RECRUITING
Grand Island
Ohio
Oncology Hematology Care Clinical Trials
RECRUITING
Cincinnati
Cleveland Clinic
ACTIVE_NOT_RECRUITING
Cleveland
University Hospital - Cleveland Medical Center
RECRUITING
Cleveland
Zangmeister Cancer Center
RECRUITING
Columbus
Oregon
Oncology Associates of Oregon
RECRUITING
Eugene
Pennsylvania
UPMC Hillman Cancer Center
WITHDRAWN
Pittsburgh
South Carolina
Medical University of South Carolina Hollings Cancer Center
RECRUITING
Charleston
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Virginia
Oncology & Hematology Associates of Southwest Virginia
RECRUITING
Blacksburg
Universtity of Virginia Health System
RECRUITING
Charlottesville
Virginia Cancer Specialists Research Institute
RECRUITING
Fairfax
Washington
Northwest Cancer Specialists
RECRUITING
Vancouver
Wisconsin
Marshfield Medical Center
RECRUITING
Marshfield
Contact Information
Primary
Puma Biotechnology, Inc. Clinical Operations Senior Director
ClinicalTrials@pumabiotechnology.com
(424) 248-6500
Time Frame
Start Date:2024-02-08
Estimated Completion Date:2027-10-31
Participants
Target number of participants:80
Treatments
Experimental: 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