NCT04192981

GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety of the study drug, GDC-0084, in combination with radiation therapy in people who have solid tumor brain metastases or leptomeningeal metastases. All participants will have cancer with a PIK3CA mutation. The researchers will test increasing doses of GDC-0084 to find the highest dose that causes few or mild side effects in participants. The study will also try to find out if the combination of the study drug with radiation is effective against participants' cancer.

Conditions

• Brain Metastases
• Leptomeningeal Metastasis

Interventions

Type	Name	Description
DRUG	GDC-0084	GDC-0084 in 3 + 3 dose-escalation in 3 cohorts: 45, 60, 75 mg daily
RADIATION	whole brain radiation therapy radiation	30Gy in 10 fractions

Timeline

• Start date: 2019-12-06
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-12-10
• Last updated: 2025-04-17

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study