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NCT02070549 · ClinicalTrials.gov registry record · Phase 1
Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 11
- Study locations
NCT02070549: Completed Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT02070549 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (74% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02070549, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of trametinib in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib may stop the growth of tumor cells by blocking proteins needed for cell growth. When these proteins are blocked, the growth of cancer cells may be stopped and the cancer cells will then die. Hepatic dysfunction is frequently found in patients with advanced cancer and usually prevents patients from receiving standard treatments or from participating in clinical trials. Patients may also need dose adjustments or absorb drugs differently. Trametinib may be a better treatment for patients with advanced cancers and hepatic dysfunction.
Primary Outcome
Dose escalation and determination of the maximum tolerated dose will be carried out separately for each cohort or stratum. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a sub-analysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitel
Conditions Studied
Interventions
- DRUG Trametinib
Study Locations (11)
Ontario
- Juravinski Cancer Centre at Hamilton Health Sciences - Hamilton
- University Health Network-Princess Margaret Hospital - Toronto
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Florida
- Moffitt Cancer Center - Tampa
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-03-10 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 1 |
What the finished NCT02070549 record still lists
NCT02070549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Trametinib is the first listed.
NCT02070549 lists 11 locations in 10 states (Ontario, California, Florida).
Frequently Asked Questions
What is clinical trial NCT02070549 about?
NCT02070549 is a clinical study titled "Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction". This phase I trial studies the side effects and best dose of trametinib in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib may stop the growth of tumo...
What is the current status of trial NCT02070549?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2014-03-10. Estimated completion is 2024-12-18.
What conditions does trial NCT02070549 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Liver, Unresectable Solid Neoplasm.
What interventions are being tested in trial NCT02070549?
The interventions under investigation include: Trametinib (DRUG).
Who is sponsoring clinical trial NCT02070549?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02070549 being conducted?
This trial has 11 study locations across California, Florida, Illinois, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02070549's enrollment target sits among peer trials
46 54th of 108 higher than 55 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm 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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