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NCT02015117 · ClinicalTrials.gov registry record · Phase 1
Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase 1 study of Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02015117: Active Phase 1 study of Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).
NCT02015117 is a Phase 1 study of Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 88-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02015117, a Phase 1 study of Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of trametinib with or without whole brain radiation therapy in treating patients with brain metastases. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs, such as trametinib, may make tumor cells more sensitive to radiation therapy. Giving trametinib with whole brain radiation therapy may be a better treatment for brain metastases.
Primary Outcome
Frequency of DLTs will be assessed by assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse (CTCAE) version 5.0. DLTs will be summarized by dose level.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Trametinib
- OTHER Pharmacological Study
- RADIATION Whole-Brain Radiotherapy
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-04-28 |
| Est. Completion | 2026-10-08 |
| Phase | Phase 1 |
What the registry record for NCT02015117 still lists
NCT02015117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 88-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Metastatic Malignant Neoplasm in the Brain appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02015117 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02015117 about?
NCT02015117 is a clinical study titled "Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases". This phase I trial studies the side effects and best dose of trametinib with or without whole brain radiation therapy in treating patients with brain metastases. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x...
What is the current status of trial NCT02015117?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-04-28. Estimated completion is 2026-10-08.
What conditions does trial NCT02015117 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Brain.
What interventions are being tested in trial NCT02015117?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Trametinib (DRUG), Pharmacological Study (OTHER), Whole-Brain Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT02015117?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02015117 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Malignant Neoplasm in the Brain
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Where NCT02015117's enrollment target sits among peer trials
10 38th of 43 higher than 4 of 43 other Metastatic Malignant Neoplasm in the Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Brain 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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