A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony rozpoznaniem drobnokomórkowy rak płuca
- •Wcześniejsze leczenie chemioterapią na bazie platyny i immunoterapią
- •Widoczna choroba możliwa do zmierzenia
✗ Disqualifies
- •Wcześniejsze leczenie lekami ukierunkowanymi na białko Aurora kinase A, w tym alisertibem
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 30, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (7)
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Quiron Dexeus
Barcelona, Spain
START Barcelona - HM Nou Delfos
Barcelona, Spain
START Rioja - Hospital de San Pedro
Logroño, Spain
Hospital Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Spain
Hospital Universitario Virgen Del Rocío
Seville, Spain
Trial contact
Puma Biotechnology, Inc. Clinical Operations Senior Director
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/15/2026.
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