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NCT06095505PHASE2Recruiting

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

Puma Biotechnology, Inc.

Start Date

2/8/2024

Completion Date

4/30/2028

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/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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Alisertib

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Conditions

Small Cell Lung Cancer

Locations

Southern Cancer Center

Daphne, Alabama 36526

United States

The Oncology Institute of Hope and Innovation

Long Beach, California 90805

United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado 80124

United States

Georgetown Lombardi Cancer Center

Washington D.C., District of Columbia 20057

United States

Clermont Oncology Center

Clermont, Florida 64711

United States

The Oncology Institute of Hope and Innovation

Fort Lauderdale, Florida 33316

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Illinois Cancer Specialists

Niles, Illinois 60714

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Minnesota Oncology Hematology

Burnsville, Minnesota 55337

United States

Nebraska Cancer Specialists

Grand Island, Nebraska 68803

United States

Oncology Hematology Care Clinical Trials

Cincinnati, Ohio 45226

United States

University Hospital - Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Zangmeister Cancer Center

Columbus, Ohio 43219

United States

Oncology Associates of Oregon

Eugene, Oregon 97401

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina 29425

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas 75246

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Oncology & Hematology Associates of Southwest Virginia

Blacksburg, Virginia 24073

United States

Universtity of Virginia Health System

Charlottesville, Virginia 22908

United States

Virginia Cancer Specialists Research Institute

Fairfax, Virginia 22031

United States

Northwest Cancer Specialists

Vancouver, Washington 98686

United States

Marshfield Medical Center

Marshfield, Wisconsin 54449

United States