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NCT01828021 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer
A Phase 2 study, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01828021: Completed Phase 2 study, sponsored by MacroGenics.
NCT01828021 is a Phase 2 study that has completed, run by MacroGenics. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01828021, a Phase 2 study, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if margetuximab is effective in the treatment of certain patients with relapsed or refractory advanced breast cancer.
Primary Outcome
Response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria based on Cycle 2, Day 21 computed tomography (CT) scans. Response is categorized as complete response (CR): disappearance of all target lesions, confirmed at ≥ 4 weeks; partial response (PR): ≥ 30% decrease in target lesions from baseline, confirmed at ≥ 4 weeks; progressive disease (PD): ≥ 20% increase over smallest sum observed with an absolute increase of at least 5 mm, or appearance of new lesions; and stabl
Interventions
- BIOLOGICAL Margetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-03 |
| Est. Completion | 2017-04-14 |
| Phase | Phase 2 |
What the finished NCT01828021 record still lists
NCT01828021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Margetuximab is the first listed.
NCT01828021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01828021 about?
NCT01828021 is a clinical study titled "Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer". The purpose of this study is to determine if margetuximab is effective in the treatment of certain patients with relapsed or refractory advanced breast cancer.
What is the current status of trial NCT01828021?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2013-03. Estimated completion is 2017-04-14.
What interventions are being tested in trial NCT01828021?
The interventions under investigation include: Margetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01828021?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01828021's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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