A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Purpose
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.
Condition
- Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Alisertib |
50 mg of alisertib PO BID on days 1-7 of each 21-day cycle |
|
Recruiting Locations
Georgetown Lombardi Cancer Center
Washington, District of Columbia 20057
Washington, District of Columbia 20057
More Details
- Status
- Recruiting
- Sponsor
- Puma Biotechnology, Inc.
Study Contact
Puma Biotechnology, Inc. Clinical Operations Senior Director(424) 248-6500
ClinicalTrials@pumabiotechnology.com