Paxalisib for Central Nervous System Lymphoma
Trial Summary
What is the purpose of this trial?
This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot take strong CYP3A4 inhibitors or inducers, as they may affect the study drug. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug Paxalisib for central nervous system lymphoma?
While there is no direct data on Paxalisib for central nervous system lymphoma, similar treatments like ibrutinib have shown encouraging results, with a 58% response rate in trials for similar conditions. Additionally, targeting pathways like PI3-kinase, which Paxalisib affects, is being actively explored in clinical trials for related lymphomas.12345
How is the drug Paxalisib unique in treating central nervous system lymphoma?
Research Team
Lakshmi Nayak
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Adults with confirmed recurrent or refractory primary DLBCL CNS lymphoma, who have measurable disease on MRI and are stable after previous treatments, can join. They must be able to undergo MRI scans, have good organ function, use effective contraception if applicable, and not require high doses of steroids. Excluded are those with other active cancers or infections like HIV/Hepatitis B/C, allergy to Paxalisib components, uncontrolled illnesses or hypertension.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Paxalisib (GDC-0084) in 28-day cycles for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Paxalisib
Paxalisib is already approved in United States for the following indications:
- None approved; Orphan Drug Designation for glioblastoma, diffuse intrinsic pontine glioma, and atypical teratoid/rhabdoid tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lakshmi Nayak
Lead Sponsor
Lakshmi Nayak, MD
Lead Sponsor
Kazia Therapeutics Limited
Industry Sponsor