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NCT02013804 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies
A Phase 1 study of Advanced Malignancies, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 6
- Study locations
NCT02013804: Completed Phase 1 study of Advanced Malignancies, sponsored by MedImmune.
NCT02013804 is a Phase 1 study of Advanced Malignancies that has completed, run by MedImmune. The registered enrollment target is 58 participants, below the 83-participant average among 10 other Advanced Malignancies trials with a reported enrollment target (30% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013804, a Phase 1 study of Advanced Malignancies, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514) to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in adult subjects with solid tumors.
Primary Outcome
The primary objectives are to assess the safety and tolerability of multiple doses of MEDI0680 (AMP-514) and define the maximum tolerated dose (MTD) or highest protocol-defined dose of MEDI0680 (AMP-514) in the absence of exceeding the MTD.
Conditions Studied
Interventions
- DRUG MEDI0680 (AMP-514)
Study Locations (6)
Connecticut
- Research Site - New Haven
Michigan
- Research Site - Detroit
New York
- Research Site - The Bronx
Oregon
- Research Site - Portland
Tennessee
- Research Site - Nashville
Texas
- Research Site - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2013-12-19 |
| Est. Completion | 2017-05-18 |
| Phase | Phase 1 |
What the finished NCT02013804 record still lists
NCT02013804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 83-participant average among 10 other Advanced Malignancies trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Advanced Malignancies appearing as the primary indexed condition, and to 1 intervention - of which MEDI0680 (AMP-514) is the first listed.
NCT02013804 lists 6 locations in 6 states (Connecticut, Michigan, New York).
Frequently Asked Questions
What is clinical trial NCT02013804 about?
NCT02013804 is a clinical study titled "A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies". This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514) to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in adult subjects with solid tumors.
What is the current status of trial NCT02013804?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2013-12-19. Estimated completion is 2017-05-18.
What conditions does trial NCT02013804 study?
This clinical trial studies the following conditions: Advanced Malignancies.
What interventions are being tested in trial NCT02013804?
The interventions under investigation include: MEDI0680 (AMP-514) (DRUG).
Who is sponsoring clinical trial NCT02013804?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02013804 being conducted?
This trial has 6 study locations across Connecticut, Michigan, New York, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02013804's enrollment target sits among peer trials
58 4th of 10 higher than 7 of 10 other Advanced Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignancies 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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