A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Puma Biotechnology, Inc.

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 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: * 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.

Interventions

Drug
Alisertib
Alisertib enteric-coated tablets

Locations (30)

Southern Cancer Center
Daphne, Alabama
The Oncology Institute of Hope and Innovation
Long Beach, California
Rocky Mountain Cancer Centers
Lone Tree, Colorado
Georgetown Lombardi Cancer Center
Washington D.C., District of Columbia
Clermont Oncology Center
Clermont, Florida
The Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida