A Phase 2 Study of Paxalisib (GDC-0084) in Recurrent or Refractory Primary Central Nervous System Lymphoma (PCNSL)
Lakshmi Nayak, MD
Summary
This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)
Description
This is an open-label, phase 2 study to determine the efficacy of Paxalisib (GDC-0084) in 25 patients with recurrent or refractory primary central nervous system lymphoma (R/R PCNSL. * The name of the study drug involved in this study is Paxalisib (GDC-0084). * The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. * It is expected that about 25 participants will take part in this research study for up to 24 months as long as there is no serious side effects and disease progression. This research study is a Phase 2 cli…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be able to understand and willing to sign a written informed consent document. * Participant must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. * Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. * Participants must be at least 18 years old on day of signi…
Interventions
- DrugPAXALISIB
Each study treatment cycle lasts 28 days, up to 24 months. Oral, daily, dosage per protocol
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts