Clinical trial NCT06095505: A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Official title: A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Alisertib
SCLC
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR) within biomarker-defined subgroup
timeFrame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
measure: Duration of response (DOR) within biomarker-defined subgroup
timeFrame: From start date of response (after date of first dose) to first PD, assessed up to 36 months
measure: Disease Control Rate (DCR) within biomarker-defined subgroup
timeFrame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
measure: Progression Free Survival (PFS) within biomarker-defined subgroup
timeFrame: From date of first dose to date of recurrence, progression or death, assessed up to 36 months
measure: Overall Survival (OS) within biomarker-defined subgroup
timeFrame: From date of first dose to death, assessed up to 36 months
Secondary outcomes:
measure: Objective response rate (ORR) in the enrolled patient population
timeFrame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
measure: Duration of response (DOR) in the enrolled patient population
timeFrame: From start date of response (after date of first dose) to first PD, assessed up to 36 months
measure: Disease Control Rate (DCR) in the enrolled patient population
timeFrame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
measure: Progression Free Survival (PFS) in the enrolled patient population
timeFrame: From date of first dose to date of recurrence, progression or death, assessed up to 36 months
measure: Overall Survival (OS) in the enrolled patient population
timeFrame: From date of first dose to death, assessed up to 36 months
measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population
timeFrame: From date of first dose through last dose plus 28 days, assessed up to 36 months
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center
state: Alabama
city: Long Beach
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Washington
country: United States
facility: Georgetown Lombardi Cancer Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: The Oncology Institute of Hope and Innovation
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Cincinnati
country: United States
facility: Oncology Hematology Care Clinical Trials
state: Ohio
city: Cleveland
country: United States
facility: University Hospital - Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Zangmeister Cancer Center
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Blacksburg
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia
state: Virginia
city: Charlottesville
country: United States
facility: Universtity of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists Research Institute
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Marshfield
country: United States
facility: Marshfield Medical Center
state: Wisconsin
Study officials:
affiliation: Puma Biotechnology, Inc.
name: Chief Scientific Officer
role: STUDY_DIRECTOR
References: