Trials / Recruiting
RecruitingNCT06095505
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Puma Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alisertib | Alisertib enteric-coated tablets |
Timeline
- Start date
- 2024-02-08
- Primary completion
- 2027-04-30
- Completion
- 2027-10-31
- First posted
- 2023-10-23
- Last updated
- 2026-02-17
Locations
30 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06095505. Inclusion in this directory is not an endorsement.