Alisertib plus paclitaxel for small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 open-label trial in people with small cell lung cancer who have progressed after platinum-based therapy and an anti-PD-1/PD-L1 agent. The study uses cohorts to escalate alisertib from 30 mg BID in 10 patients per cohort, up to a planned maximum of 70 mg BID, with monitoring for adverse events in Cycle 1 (Days 1-21). Safety data from Cycle 1 determine whether the dose is increased for the next cohort. All participants receive alisertib in combination with paclitaxel, with ongoing assessment of toxicity by NCI CTCAE v5.0. Eligibility requires measurable disease and prior limited systemic therapy for SCLC. Enrollment is limited to sites including Reno, Paris, and Alicante.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion 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 exclusion criteria. The study center will determine if you meet all of the criteria.

Where it's running

• Cancer Care Specialists
  Reno, Nevada, United States Recruiting
• Institut Curie Paris
  Paris, France Recruiting
• Hospital General Universitario Dr. Balmis
  Alicante, Spain Recruiting
• Hospital Del Mar
  Barcelona, Spain Recruiting
• Hospital Quiron Dexeus
  Barcelona, Spain Recruiting
• START Barcelona - HM Nou Delfos
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Puma Biotechnology, Inc. Clinical Operations Senior Director
• Email: ClinicalTrials@pumabiotechnology.com
• Phone: 424-248-6500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.