EICHORCondition: Small Cell Lung Cancer · Sponsor: Puma Biotechnology, Inc.
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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.
This description comes directly from the study's public registry record.
Puma Biotechnology, Inc. Clinical Operations Senior Director · (424) 248-6500 · ClinicalTrials@pumabiotechnology.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Southern Cancer Center | Daphne, Alabama, United States | Recruiting |
| The Oncology Institute of Hope and Innovation | Long Beach, California, United States | Recruiting |
| Rocky Mountain Cancer Centers | Lone Tree, Colorado, United States | Recruiting |
| Georgetown Lombardi Cancer Center | Washington D.C., District of Columbia, United States | Recruiting |
| Clermont Oncology Center | Clermont, Florida, United States | Recruiting |
| The Oncology Institute of Hope and Innovation | Fort Lauderdale, Florida, United States | Recruiting |
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| Illinois Cancer Specialists | Niles, Illinois, United States | Recruiting |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis, Indiana, United States | Recruiting |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore, Maryland, United States | Recruiting |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States | Recruiting |
| Dana Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
+ 18 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT06095505