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NCT04192981 · ClinicalTrials.gov registry record · Phase 1
GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases
A Phase 1 study of Brain Metastases and Leptomeningeal Metastasis, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 9
- Study locations
NCT04192981: Active Phase 1 study of Brain Metastases and Leptomeningeal Metastasis, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04192981 is a Phase 1 study of Brain Metastases and Leptomeningeal Metastasis that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 21 participants, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (90% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04192981, a Phase 1 study of Brain Metastases and Leptomeningeal Metastasis, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
Four dose levels will be examined and the maximum tolerated dose (MTD) will be identified. The standard 3+3 dose-escalation scheme for this study is as follows. Patients will be accrued to the study in cohorts of 3. For any given dose an initial cohort of 3 patients will be treated at that dose.The dose level will be escalated if none of the 3 exhibits any dose limiting toxicity (DLT).
Conditions Studied
Interventions
- DRUG GDC-0084
- RADIATION whole brain radiation therapy radiation
Study Locations (9)
New York
- Memorial Sloan Kettering Commack (Consent only) - Commack
- Memorial Sloan Kettering Westchester (All protocol activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All protocol activities) - New York
- Memorial Sloan Kettering Nassau (Consent only) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Consent only) - Basking Ridge
- Memorial Sloan Kettering Monmouth (All protocol activities) - Middletown
- Memorial Sloan Kettering Bergen (Consent only) - Montvale
Florida
- BAPTIST ALLIANCE - MCI (Data Collection Only) - Miami
Washington
- University of Washington (Data Collection AND Data Analysis) - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-12-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT04192981 still lists
NCT04192981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Brain Metastases appearing as the primary indexed condition, and to 2 interventions - of which GDC-0084 is the first listed.
NCT04192981 lists 9 locations in 4 states (New York, New Jersey, Florida).
Frequently Asked Questions
What is clinical trial NCT04192981 about?
NCT04192981 is a clinical study titled "GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases". 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 th...
What is the current status of trial NCT04192981?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-12-06. Estimated completion is 2026-12.
What conditions does trial NCT04192981 study?
This clinical trial studies the following conditions: Brain Metastases, Leptomeningeal Metastasis.
What interventions are being tested in trial NCT04192981?
The interventions under investigation include: GDC-0084 (DRUG), whole brain radiation therapy radiation (RADIATION).
Who is sponsoring clinical trial NCT04192981?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04192981 being conducted?
This trial has 9 study locations across Florida, New Jersey, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04192981's enrollment target sits among peer trials
21 49th of 67 higher than 18 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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