Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

24mo left

Started Sep 2026

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

March 6, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed

7 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Small Cell Lung Cancer ( SCLC )

Keywords

alisertibSCLC

Outcome Measures

Primary Outcomes (1)

Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after the last dose.
From date of first dose through last dose plus 28 days, assessed up to 24 months

Secondary Outcomes (5)

Objective Response Rate (ORR)
From date of first dose to first confirmed Complete or Partial Response, assessed up to 24 months
Duration of response (DOR)
From start date of response to first PD or death, assessed up to 24 months
Disease Control Rate (DCR)
From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 24 months
Progression Free Survival (PFS)
From date of first dose to date of recurrence, progression or death, assessed up to 24 months
Overall Survival (OS)
From date of first dose to death, assessed up to 24 months

Study Arms (5)

Cohort 1: Alisertib 30 mg BID + Paclitaxel

EXPERIMENTAL

Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.