A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alisertib 50 mg of alisertib PO BID on days 1-7 of each 21-day cycle |
Drug: Alisertib
Alisertib enteric-coated tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Puma Biotechnology, Inc.
Investigators
- Study Director: Chief Scientific Officer, Puma Biotechnology, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PUMA-ALI-4201