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

Study Overview
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Brief Summary
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PUMA-ALI-4201 is a Phase 2 study evaluating alisertib in patients with pathologically-confirmed extensive-stage small cell lung cancer (ES-SCLC) following progression on or after first-line treatment with platinum-based chemotherapy along with an anti-PDL-1 immunotherapy agent. This study is intended to evaluate the efficacy, safety, and pharmacokinetics of alisertib and to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment.

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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Alisertib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years at signing of informed consent Pathologically confirmed ES-SCLC Progression on or after first-line platinum-based chemotherapy. Patients must have also received a prior anti-PDL-1 immunotherapy agent 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alisertib<br>50 mg of alisertib PO BID on days 1-7 of each 21-day cycle | Drug: Alisertib<br>* Alisertib enteric-coated tablets<br>* Other names: MLN8237;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alisertib, SCLC