A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPuma Biotechnology, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years at signing of informed consent
Pathologically confirmed SCLC
Prior treatment with one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens
Disqualifiers
Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
Trial design
Design model
Single group
Treatments tested in this trial
Alisertib
DrugAlisertib enteric-coated tablets
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: AlisertibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov