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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 is a Phase 1 study that has completed, run by Polaris Group. The registered enrollment target is 15 participants.

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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.

Interventions

  • DRUG ADI-PEG 20

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2014-04
Est. Completion 2016-04
Phase Phase 1

Sponsor

Polaris Group

13 total trials

What the Registry Record Tells You About NCT01948843

The ClinicalTrials.gov registry entry for NCT01948843 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Polaris Group, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 is the first listed.

NCT01948843 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.