RecruitingRecruiting
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
NCT06095505 · Puma Biotechnology, Inc.
In plain English
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Official title
A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
About this study
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/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. 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 criteria
Inclusion Criteria:
* Aged ≥18 years at signing of informed consent
* Pathologically confirmed SCLC
* Prior treatment with one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens
Exclusion Criteria:
* Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Study design
Enrollment target: 120 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-08
Estimated completion: 2028-04-30
Last updated: 2026-06-05
Interventions
Drug: Alisertib
Primary outcomes
- • Objective response rate (ORR) within biomarker-defined subgroup (From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months)
- • Duration of response (DOR) within biomarker-defined subgroup (From start date of response (after date of first dose) to first PD, assessed up to 36 months)
- • Disease Control Rate (DCR) within biomarker-defined subgroup (From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months)
Sponsor
Puma Biotechnology, Inc. · industry
Contacts & investigators
ContactPuma Biotechnology, Inc. Clinical Operations Senior Director · contact · ClinicalTrials@pumabiotechnology.com · (424) 248-6500
InvestigatorChief Scientific Officer · study_director, Puma Biotechnology, Inc.
All locations (30)
Southern Cancer CenterRecruiting
Daphne, Alabama, United States
The Oncology Institute of Hope and InnovationRecruiting
Long Beach, California, United States
Rocky Mountain Cancer CentersRecruiting
Lone Tree, Colorado, United States
Georgetown Lombardi Cancer CenterRecruiting
Washington D.C., District of Columbia, United States
Clermont Oncology CenterRecruiting
Clermont, Florida, United States
The Oncology Institute of Hope and InnovationRecruiting
Fort Lauderdale, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Illinois Cancer SpecialistsRecruiting
Niles, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterRecruiting
Indianapolis, Indiana, United States
University of Maryland Greenebaum Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Minnesota Oncology HematologyRecruiting
Burnsville, Minnesota, United States
Nebraska Cancer SpecialistsRecruiting
Grand Island, Nebraska, United States
Oncology Hematology Care Clinical TrialsRecruiting
Cincinnati, Ohio, United States
University Hospital - Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Cleveland ClinicActive Not Recruiting
Cleveland, Ohio, United States
Zangmeister Cancer CenterRecruiting
Columbus, Ohio, United States
Oncology Associates of OregonRecruiting
Eugene, Oregon, United States
UPMC Hillman Cancer CenterWithdrawn
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Hollings Cancer CenterRecruiting
Charleston, South Carolina, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Oncology & Hematology Associates of Southwest VirginiaRecruiting
Blacksburg, Virginia, United States
Universtity of Virginia Health SystemCompleted
Charlottesville, Virginia, United States
Virginia Cancer Specialists Research InstituteRecruiting
Fairfax, Virginia, United States
Northwest Cancer SpecialistsRecruiting
Vancouver, Washington, United States
Marshfield Medical CenterRecruiting
Marshfield, Wisconsin, United States