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NCT01948843 · ClinicalTrials.gov registry record · Phase 1
Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer
A Phase 1 study, sponsored by Polaris Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01948843: Completed Phase 1 study, sponsored by Polaris Group.
NCT01948843 is a Phase 1 study that has completed, run by Polaris Group. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01948843, a Phase 1 study, has completed, sponsored by Polaris Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy Doxorubicin and the safety and potential efficacy of this combination will be explored in patients with HER2 Negative Metastatic Breast Cancer.
Primary Outcome
Assessment of safety and tolerability of ADI-PEG 20 in combination with doxorubicin in HER2 negative metastatic breast cancer
Interventions
- DRUG ADI-PEG 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01948843 record still lists
NCT01948843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 is the first listed.
NCT01948843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01948843 about?
NCT01948843 is a clinical study titled "Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer". Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well...
What is the current status of trial NCT01948843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01948843?
The interventions under investigation include: ADI-PEG 20 (DRUG).
Who is sponsoring clinical trial NCT01948843?
This trial is sponsored by Polaris Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01948843's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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