Trials / Completed
CompletedNCT01516307
Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects
A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 349 (actual)
- Sponsor
- OBI Pharma, Inc · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OPT-822/OPT-821(30 μg/100 μg) | Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection. |
| BIOLOGICAL | Phosphate Buffer Saline (PBS) | Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. |
| DRUG | Cyclophosphamide | Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2016-08-01
- Completion
- 2019-08-01
- First posted
- 2012-01-24
- Last updated
- 2020-09-16
Locations
43 sites across 5 countries: United States, China, India, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01516307. Inclusion in this directory is not an endorsement.