Small Cell Lung Cancer
Conditions
Keywords
Alisertib, SCLC
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/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.
Interventions
DRUGAlisertib
Alisertib enteric-coated tablets
Sponsors
Puma Biotechnology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTPuma Biotechnology, Inc. Clinical Operations Senior Director
STUDY_DIRECTORChief Scientific Officer
Puma Biotechnology, Inc.
Outcome results
None listed