A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
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Sponsored by Puma Biotechnology, Inc. (industry) · PBYI — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
120estimated
Sites
30
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-02-08 | actual | When the study began enrolling |
| Primary completion | 2027-10-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Small Cell Lung Cancer
Intervention
- Drug: Alisertib — also filed as PB-8237, MLN8237
Primary outcomes
what the primary-completion date above is the date OFObjective response rate (ORR) within biomarker-defined subgroup
measured 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
measured 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
measured 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
measured From date of first dose to date of recurrence, progression or death, assessed up to 36 months
Overall Survival (OS) within biomarker-defined subgroup
measured From date of first dose to death, assessed up to 36 months
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