A Phase I Study of GDC-0084 with Radiation Therapy for People with PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases


Full Title

A Phase I Study with Expansion Cohort of Concurrent GDC-0084 with Radiation Therapy for Patients with Solid Tumor Brain Metastases or Leptomeningeal Metastases Harboring PI3K Pathway Mutations


PIK3CA gene mutations are common in many types of cancer, and they cause radiation therapy to be less effective. GDC-0084 is an investigational drug that reduces the activity of PIK3CA-related signaling in cells.

In this study, researchers want to find the highest dose of GDC-0084 that can be given safely in patients with PIK3CA-mutated cancers that have spread to the brain or the membranes lining the brain and spinal cord (leptomeningeal metastases). They will also see if the combination of GDC-0084 is effective against these cancers. GDC-0084 is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a solid tumor that has PIK3CA mutations and has spread to the brain or leptomeninges.
  • Patients must be candidates for radiation therapy.
  • At least one week must pass between the completion of prior treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.



For more information about this study and to inquire about eligibility, please contact Dr. Brandon Imber at 631-212-6346.




Phase I (phase 1)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID