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A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

NCT06095505

RecruitingPhase 2

Sponsor: Puma Biotechnology, Inc.

Conditions: Small Cell Lung Cancer

Interventions: Alisertib

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (30)
  • Daphne, Alabama, United States
  • Long Beach, California, United States
  • Lone Tree, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Clermont, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Tampa, Florida, United States
  • Niles, Illinois, United States
  • Indianapolis, Indiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Burnsville, Minnesota, United States
  • Grand Island, Nebraska, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Eugene, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Blacksburg, Virginia, United States
  • Charlottesville, Virginia, United States
  • Fairfax, Virginia, United States
  • Vancouver, Washington, United States
  • Marshfield, Wisconsin, United States