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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Alisertib enteric-coated tablets
Southern Cancer Center
Daphne, Alabama, United States
RECRUITINGThe Oncology Institute of Hope and Innovation
Long Beach, California, United States
RECRUITINGRocky Mountain Cancer Centers
Lone Tree, Colorado, United States
RECRUITINGGeorgetown Lombardi Cancer Center
Washington D.C., District of Columbia, United States
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From date of first dose to death, assessed up to 36 months
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: From date of first dose to death, assessed up to 36 months
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population
Puma Biotechnology, Inc. Clinical Operations Senior Director
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Clermont Oncology Center
Clermont, Florida, United States
RECRUITINGThe Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGIllinois Cancer Specialists
Niles, Illinois, United States
RECRUITINGIndiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
RECRUITINGUniversity of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
RECRUITING...and 20 more locations
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.
Time frame: From date of first dose through last dose plus 28 days, assessed up to 36 months