Actively Recruiting
Phase 2 Open-Label Study of Paxalisib GDC-0084 for Recurrent or Refractory Primary Central Nervous System Lymphoma
Led by Lakshmi Nayak, MD · Updated on 2026-08-05
25
Participants Needed
2
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the drug Paxalisib GDC-0084 as a potential treatment for adults with recurrent or refractory primary central nervous system lymphoma PCNSL. This open-label phase 2 study aims to determine the drugs effectiveness and safety in 25 participants who have this condition. The study is led by Lakshmi Nayak, MD, and involves patients whose disease has returned or not responded to prior treatments. Participants will receive Paxalisib orally once daily in 28-day treatment cycles. Treatment may continue for up to 24 months as long as participants do not experience serious side effects or disease progression. The study includes screening for eligibility, treatment cycles, and follow-up visits to monitor participants throughout the trial. During the study, participants will undergo various evaluations including MRI scans, laboratory tests, and clinical assessments to track disease status and side effects. Researchers will measure the objective response rate and other outcomes such as overall survival and progression-free survival over up to 24 months. Participants must comply with scheduled visits and treatment requirements, and safety will be closely monitored during and after treatment.
CONDITIONS
Brief Title
Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL
Research Team
L
Lakshmi Nayak, MD
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