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NCT02248805 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of MGD007 in Relapsed/Refractory Metastatic Colorectal Carcinoma
A Phase 1 study of Colorectal Carcinoma, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 8
- Study locations
NCT02248805: Completed Phase 1 study of Colorectal Carcinoma, sponsored by MacroGenics.
NCT02248805 is a Phase 1 study of Colorectal Carcinoma that has completed, run by MacroGenics. The registered enrollment target is 95 participants, below the 1,095-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (91% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02248805, a Phase 1 study of Colorectal Carcinoma, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 8
- Study locations
Study Summary
The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) and schedule of MGD007 administered to patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 will also be assessed.
Primary Outcome
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit. The MTD will be defined separately for both the weekly and every three week schedules of MGD007 administration, and will be determined as the highest dose level at which the incidence of DLT is \< 33% during the first cycle of MGD007 treatment.
Conditions Studied
Interventions
- DRUG MGD007
Study Locations (8)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
North Carolina
- Duke University Medical Center - Durham
- Carolina Biooncology Institute - Huntersville
Connecticut
- Yale University, Yale Cancer Center - New Haven
Florida
- H. Lee Moffitt Cancer Center & Research Institute, Inc - Tampa
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2014-10 |
| Est. Completion | 2018-07-02 |
| Phase | Phase 1 |
What the finished NCT02248805 record still lists
NCT02248805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 1,095-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Colorectal Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which MGD007 is the first listed.
NCT02248805 lists 8 locations in 6 states (Massachusetts, North Carolina, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02248805 about?
NCT02248805 is a clinical study titled "Phase 1 Study of MGD007 in Relapsed/Refractory Metastatic Colorectal Carcinoma". The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) and schedule of MGD007 administered to patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD0...
What is the current status of trial NCT02248805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2014-10. Estimated completion is 2018-07-02.
What conditions does trial NCT02248805 study?
This clinical trial studies the following conditions: Colorectal Carcinoma.
What interventions are being tested in trial NCT02248805?
The interventions under investigation include: MGD007 (DRUG).
Who is sponsoring clinical trial NCT02248805?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02248805 being conducted?
This trial has 8 study locations across Connecticut, Florida, Maryland, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02248805's enrollment target sits among peer trials
95 32nd of 53 higher than 22 of 53 other Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Carcinoma 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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