A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
- Registration Number
- NCT06095505
- Lead Sponsor
- Puma Biotechnology, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alisertib Alisertib 50 mg of alisertib PO BID on days 1-7 of each 21-day cycle
- Primary Outcome Measures
Name Time Method Disease Control Rate (DCR) within biomarker-defined subgroup From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months 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.
Progression Free Survival (PFS) within biomarker-defined subgroup From date of first dose to date of recurrence, progression or death, assessed up to 36 months 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.
Overall Survival (OS) within biomarker-defined subgroup From date of first dose to death, assessed up to 36 months 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.
Objective response rate (ORR) within biomarker-defined subgroup From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
Duration of response (DOR) within biomarker-defined subgroup From start date of response (after date of first dose) to first PD, assessed up to 36 months 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Overall Survival (OS) in the enrolled patient population From date of first dose to death, assessed up to 36 months 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.
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 Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
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 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.
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 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.
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population From date of first dose through last dose plus 28 days, assessed up to 36 months 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.
Trial Locations
- Locations (26)
Southern Cancer Center
🇺🇸Daphne, Alabama, United States
The Oncology Institute of Hope and Innovation
🇺🇸Fort Lauderdale, Florida, United States
Rocky Mountain Cancer Centers
🇺🇸Lone Tree, Colorado, United States
Georgetown Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
University of Maryland Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Minnesota Oncology Hematology
🇺🇸Burnsville, Minnesota, United States
Oncology Hematology Care Clinical Trials
🇺🇸Cincinnati, Ohio, United States
University Hospital - Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Zangmeister Cancer Center
🇺🇸Columbus, Ohio, United States
Oncology Associates of Oregon
🇺🇸Eugene, Oregon, United States
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Oncology & Hematology Associates of Southwest Virginia
🇺🇸Blacksburg, Virginia, United States
Virginia Cancer Specialists Research Institute
🇺🇸Fairfax, Virginia, United States
Universtity of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
Marshfield Medical Center
🇺🇸Marshfield, Wisconsin, United States