Trial Title:
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
NCT ID:
NCT06095505
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Conditions: Keywords:
Alisertib
SCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Alisertib
Description:
Alisertib enteric-coated tablets
Arm group label:
Alisertib
Other name:
PB-8237
Other name:
MLN8237
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.
Criteria for 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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Cancer Center
Address:
City:
Daphne
Zip:
36526
Country:
United States
Status:
Recruiting
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Long Beach
Zip:
90805
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgetown Lombardi Cancer Center
Address:
City:
Washington
Zip:
20057
Country:
United States
Status:
Recruiting
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Fort Lauderdale
Zip:
33316
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Illinois Cancer Specialists
Address:
City:
Niles
Zip:
60714
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Maryland Greenebaum Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Minnesota Oncology Hematology
Address:
City:
Burnsville
Zip:
55337
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care Clinical Trials
Address:
City:
Cincinnati
Zip:
45226
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospital - Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Zangmeister Cancer Center
Address:
City:
Columbus
Zip:
43219
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Associates of Oregon
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical University of South Carolina Hollings Cancer Center
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology & Hematology Associates of Southwest Virginia
Address:
City:
Blacksburg
Zip:
24073
Country:
United States
Status:
Recruiting
Facility:
Name:
Universtity of Virginia Health System
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists Research Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Cancer Specialists
Address:
City:
Vancouver
Zip:
98686
Country:
United States
Status:
Recruiting
Facility:
Name:
Marshfield Medical Center
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Status:
Recruiting
Start date:
February 8, 2024
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Puma Biotechnology, Inc.
Agency class:
Industry
Source:
Puma Biotechnology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095505
