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

Small Cell Lung Cancer Clinical Trial

— ALISCA-Lung1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095505
• Other study ID #: PUMA-ALI-4201
• Status: Recruiting
• Phase: Phase 2
• Start date: February 8, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: Puma Biotechnology, Inc.
• Contact: Puma Biotechnology, Inc. Clinical Operations Senior Director
• Phone: (424) 248-6500
• Email: ClinicalTrials[@]pumabiotechnology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Alisertib
Alisertib enteric-coated tablets

Locations

Country	Name	City	State
United States	Oncology & Hematology Associates of Southwest Virginia	Blacksburg	Virginia
United States	Minnesota Oncology Hematology	Burnsville	Minnesota
United States	Universtity of Virginia Health System	Charlottesville	Virginia
United States	Oncology Hematology Care Clinical Trials	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospital - Cleveland Medical Center	Cleveland	Ohio
United States	Zangmeister Cancer Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Southern Cancer Center	Daphne	Alabama
United States	Henry Ford Hospital	Detroit	Michigan
United States	Oncology Associates of Oregon	Eugene	Oregon
United States	Virginia Cancer Specialists Research Institute	Fairfax	Virginia
United States	Rocky Mountain Cancer Centers	Lone Tree	Colorado
United States	Marshfield Medical Center	Marshfield	Wisconsin
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Illinois Cancer Specialists	Niles	Illinois
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Northwest Cancer Specialists	Vancouver	Washington
United States	Georgetown Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Puma Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Objective response rate (ORR) in the enrolled patient population	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
Secondary	Duration of response (DOR) in the enrolled patient population	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
Secondary	Disease Control Rate (DCR) in the enrolled patient population	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
Secondary	Progression Free Survival (PFS) in the enrolled patient population	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
Secondary	Overall Survival (OS) in the enrolled patient population	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	Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population	Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose.	From date of first dose through last dose plus 28 days, assessed up to 36 months