Puma Biotechnology ((PBYI)) announced an update on their ongoing clinical study.
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Study Overview: Puma Biotechnology is conducting a Phase 2 study titled A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer. The study aims to evaluate the efficacy, safety, and pharmacokinetics of alisertib in patients with small cell lung cancer (SCLC) who have progressed after receiving platinum-based chemotherapy and anti-PD-L1 immunotherapy. The study seeks to identify biomarker-defined subgroups that may benefit most from alisertib treatment.
Intervention/Treatment: The study tests alisertib, an experimental drug administered as enteric-coated tablets. Patients receive 50 mg or 60 mg doses of alisertib orally, twice daily on days 1-7 of each 21-day cycle, depending on the study amendment.
Study Design: This interventional study uses a single-group model with no masking, focusing primarily on treatment. It does not involve allocation to different groups, as all participants receive the same intervention.
Study Timeline: The study began on September 27, 2023, and is currently recruiting participants. The last update was submitted on September 15, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: The progress of this study could significantly impact Puma Biotechnology’s stock performance and investor sentiment, particularly if alisertib demonstrates positive results. As the pharmaceutical industry is highly competitive, successful outcomes could position Puma Biotechnology favorably against competitors in the oncology sector.
The study is ongoing, with further details available on the ClinicalTrials portal.