A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Puma Biotechnology, Inc.
Study ID
NCT06095505
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alisertib — DRUG
    Alisertib enteric-coated tablets

Study Details

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/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. 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.

Key Dates

First listed
Oct 23, 2023
Start date
Feb 8, 2024
Status verified
Aug 2026
Primary completion
Oct 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alisertib
    50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) or 70 mg (Amendment 3 or later) of alisertib PO BID on days 1-7 of each 21-day cycle

Primary Outcome Measure

Objective response rate (ORR) within biomarker-defined subgroup [ Time Frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months ]

Central Contacts

  • Puma Biotechnology, Inc. Clinical Operations Senior Director
    (424) 248-6500
    [email protected]

Locations (30)

FacilityCityStateZIPSite coordinators
Southern Cancer CenterDaphneAlabama36526-
The Oncology Institute of Hope and InnovationLong BeachCalifornia90805-
Rocky Mountain Cancer CentersLone TreeColorado80124-
Georgetown Lombardi Cancer CenterWashington D.C.District of Columbia20057-
Clermont Oncology CenterClermontFlorida64711-
The Oncology Institute of Hope and InnovationFort LauderdaleFlorida33316-
Moffitt Cancer CenterTampaFlorida33612-
Illinois Cancer SpecialistsNilesIllinois60714-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford HospitalDetroitMichigan48202-
Minnesota Oncology HematologyBurnsvilleMinnesota55337-
Nebraska Cancer SpecialistsGrand IslandNebraska68803-
Oncology Hematology Care Clinical TrialsCincinnatiOhio45226-
Cleveland ClinicClevelandOhio44195-
University Hospital - Cleveland Medical CenterClevelandOhio44106-
Zangmeister Cancer CenterColumbusOhio43219-
Oncology Associates of OregonEugeneOregon97401-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Medical University of South Carolina Hollings Cancer CenterCharlestonSouth Carolina29425-
SCRI Oncology PartnersNashvilleTennessee37203-
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
University of Texas Southwestern Medical CenterDallasTexas75390-
Oncology & Hematology Associates of Southwest VirginiaBlacksburgVirginia24073-
Universtity of Virginia Health SystemCharlottesvilleVirginia22908-
Virginia Cancer Specialists Research InstituteFairfaxVirginia22031-
Northwest Cancer SpecialistsVancouverWashington98686-
Marshfield Medical CenterMarshfieldWisconsin54449-

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By research site
Southern Cancer Center· Daphne, ALThe Oncology Institute of Hope and Innovation· Long Beach, CARocky Mountain Cancer Centers· Lone Tree, COGeorgetown Lombardi Cancer Center· Washington D.C., DCClermont Oncology Center· Clermont, FLThe Oncology Institute of Hope and Innovation· Fort Lauderdale, FL

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