A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
ALISCA-Lung1
A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
1 other identifier
interventional
80
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2024
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
February 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
February 17, 2026
February 1, 2026
3.2 years
September 27, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Objective response rate (ORR) within biomarker-defined subgroup
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Duration of response (DOR) within biomarker-defined subgroup
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
From start date of response (after date of first dose) to first PD, assessed up to 36 months
Disease Control Rate (DCR) within biomarker-defined subgroup
Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product.
From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Progression Free Survival (PFS) within biomarker-defined subgroup
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of first dose until the first date on which recurrence, progression, or death due to any cause, is documented.
From date of first dose to date of recurrence, progression or death, assessed up to 36 months
Overall Survival (OS) within biomarker-defined subgroup
Overall survival (OS) is defined as the time from date of first dose to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
From date of first dose to death, assessed up to 36 months
Secondary Outcomes (6)
Objective response rate (ORR) in the enrolled patient population
From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Duration of response (DOR) in the enrolled patient population
From start date of response (after date of first dose) to first PD, assessed up to 36 months
Disease Control Rate (DCR) in the enrolled patient population
From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Progression Free Survival (PFS) in the enrolled patient population
From date of first dose to date of recurrence, progression or death, assessed up to 36 months
Overall Survival (OS) in the enrolled patient population
From date of first dose to death, assessed up to 36 months
- +1 more secondary outcomes
Study Arms (1)
Alisertib
EXPERIMENTAL50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) of alisertib PO BID on days 1-7 of each 21-day cycle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Scientific Officer
Puma Biotechnology, Inc.
Central Study Contacts
Puma Biotechnology, Inc. Clinical Operations Senior Director
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 23, 2023
Study Start
February 8, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
- Access Criteria
- Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge. In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.