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NCT01284231 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas
A Phase 1 study of Gastrointestinal Adenocarcinomas, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 4
- Study locations
NCT01284231: Completed Phase 1 study of Gastrointestinal Adenocarcinomas, sponsored by MedImmune.
NCT01284231 is a Phase 1 study of Gastrointestinal Adenocarcinomas that has completed, run by MedImmune. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284231, a Phase 1 study of Gastrointestinal Adenocarcinomas, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 4
- Study locations
Study Summary
To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal adenocarcinomas who have no available standard or curative treatments.
Primary Outcome
MTD/OBD will be determined based on Dose Limiting Toxicities that will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle
Conditions Studied
Interventions
- DRUG MEDI-565
Study Locations (4)
District of Columbia
- Research Site - Washington D.C.
Georgia
- Research Site - Augusta
North Carolina
- Research Site - Durham
Pennsylvania
- Research Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01284231 record still lists
NCT01284231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Gastrointestinal Adenocarcinomas appearing as the primary indexed condition, and to 1 intervention - of which MEDI-565 is the first listed.
NCT01284231 reports a single indexed study location in District of Columbia, Georgia, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01284231 about?
NCT01284231 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas". To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal adenocarcinomas who have no available standard or curative treatments.
What is the current status of trial NCT01284231?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2010-12. Estimated completion is 2015-01.
What conditions does trial NCT01284231 study?
This clinical trial studies the following conditions: Gastrointestinal Adenocarcinomas.
What interventions are being tested in trial NCT01284231?
The interventions under investigation include: MEDI-565 (DRUG).
Who is sponsoring clinical trial NCT01284231?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01284231 being conducted?
This trial has 4 study locations across District of Columbia, Georgia, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01284231's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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