GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases
Public ClinicalTrials.gov record NCT04192981. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04192981
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2019 (Actual)
- Primary completion
- Dec 2026 (Estimated)
- Completion
- Dec 2026 (Estimated)
- Last update posted
- Apr 22, 2026
2019 – 2026
United States locations
- U.S. sites
- 9
- U.S. states
- 4
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| BAPTIST ALLIANCE - MCI (Data Collection Only) | Miami | Florida | 33143 | — |
| Memorial Sloan Kettering Basking Ridge (Consent only) | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Monmouth (All protocol activities) | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen (Consent only) | Montvale | New Jersey | 07645 | — |
| Memorial Sloan Kettering Commack (Consent only) | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester (All protocol activities) | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center (All protocol activities) | New York | New York | 10065 | — |
| Memorial Sloan Kettering Nassau (Consent only) | Uniondale | New York | 11553 | — |
| University of Washington (Data Collection AND Data Analysis) | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04192981, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04192981 live on ClinicalTrials.gov.