RecruitingPhase 2NCT07465757
Official study title

A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)

Study summary

The goal of this clinical trial is to determine how well people tolerate treatment with alisertib at different doses when it is used together with paclitaxel to treat people with SCLC. The main question it aims to answer is: * What percentage of side effects, both mild and serious, do participants experience when being treated with alisertib and paclitaxel based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0)? The study will consist of different groups, called cohorts, in which alisertib will be studied at increasing doses. Participants in the first group, Cohort 1, will take 30 mg of alisertib by mouth 2 times a day. The dose will increase by 10 mg 2 times a day for each new cohort of participants joining the study. Side effects will be checked during the study, and the decision to increase the dose of alisertib will be based on the specific side effects experienced during the first 21 days of treatment for each cohort. Participants will: * take alisertib by mouth on their own 2 times a day from Day 1 through Day 7 of each 21-day cycle and will be given paclitaxel intravenously at a dose of 60 mg/m2 on Day 1 and Day 8 of each 21-day cycle. * be given a preventive treatment to increase their body defenses, called granulocyte-colony stimulating factor (G-CSF). Study staff will give G-CSF after the last dose of alisertib or paclitaxel of each 21-day cycle in which alisertib was given. * provide blood samples to evaluate the different levels of alisertib in the blood at different times. Blood samples will be collected on Days 1 and 7 of the first and second 21-day cycles of treatment. * be treated with alisertib and paclitaxel until death, worsening of the disease, unacceptable toxicity, unwillingness to continue participating in the trial, or other criteria that requires participants to stop treatment and participation in the study. * be contacted every 8 weeks after stopping alisertib and paclitaxel treatment as part of a specific study phase called the long-term follow-up period. This will last until death, unwillingness to continue participating in the trial, or until the end of the study.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAlisertib and Alisertib

Plus 4 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?11 U.S. locations

Locations may change over time.

Who runs it?Puma Biotechnology, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Puma Biotechnology, Inc.
Interventions being studied
Drug: Alisertib; Drug: Alisertib; Drug: Alisertib; Drug: Alisertib; Drug: Alisertib; Drug: Paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Aged ≥18 years at signing of informed consent
  • Pathologically confirmed SCLC
  • Prior treatment with one platinum-based chemotherapy and an anti-PD-1/PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to 2 prior treatment regimens
  • Measurable disease as defined by RECIST v1.1
Reasons someone may not be able to joinExclusion criteria

Prior treatment with an aurora kinase A (AURKA) specific-targeted or pan-Aurora- targeted agent, including alisertib, in any setting There are additional inclusion and

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cancer Care SpecialistsReno, Nevada
  • Institut Curie ParisParis
  • Hospital General Universitario Dr. BalmisAlicante
  • Hospital Del MarBarcelona
  • Hospital Quiron DexeusBarcelona
  • START Barcelona - HM Nou DelfosBarcelona
  • START Rioja - Hospital de San PedroLogroño
  • Hospital Regional Universitario de Malaga - General HospitalMálaga
  • Hospital Universitario Morales MeseguerMurcia
  • Hospital Universitario Infanta SofíaSan Sebastián de los Reyes
  • Hospital Universitario Virgen Del RocíoSeville

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 2, 2026. Always confirm current availability with the study team.

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