Trials / Completed
CompletedNCT01948843
Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer
Phase 1 Trial of ADI-PEG 20 Plus Doxorubicin in Patients With HER2 Negative Metastatic Breast Cancer or Advanced Solid Tumor
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Polaris Group · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ADI-PEG 20 |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2013-09-24
- Last updated
- 2016-04-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01948843. Inclusion in this directory is not an endorsement.