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NCT01516307 · ClinicalTrials.gov registry record · Phase 2
Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects
A Phase 2 study of Metastatic Breast Cancer, sponsored by OBI Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 349
- Enrollment target
- 20
- Study locations
NCT01516307: Completed Phase 2 study of Metastatic Breast Cancer, sponsored by OBI Pharma.
NCT01516307 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by OBI Pharma. The registered enrollment target is 349 participants, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01516307, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by OBI Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 349 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL OPT-822/OPT-821(30 μg/100 μg)
- BIOLOGICAL Phosphate Buffer Saline (PBS)
Study Locations (20)
California
- St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center - Fullerton
- University of California, San Diego (UCSD) - La Jolla
- University of California, Irvine (UCI) - Orange
- University of California, San Francisco (UCSF) - San Francisco
- Coastal Integrative Cancer Care - San Luis Obispo
- Central Coast Medical Oncology Corporation - Santa Maria
- University of California, Los Angeles (UCLA) - Santa Monica
Other
- UNIMED Medical Institute - Hong Kong
- HCG, Bangalore Institute of Oncology - Bengaluru
- Curie Manavata Cancer Centre - Mumbai
- Dong-A University Hospital - Busan
- Pusan National University Hospital - Busan
- Inha University Hospital - Chungcheongbuk-Do
- National Cancer Center - Chungcheongbuk-Do
Alabama
- The University of Alabama at Birmingham (UAB) - Birmingham
Florida
- Memorial Regional Hospital - Hollywood
Illinois
- University of Chicago Medical Center - Chicago
New York
- Weill Cornell Medical College - New York
North Carolina
- Hope Women's Cancer Center - Asheville
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2011-12 |
| Est. Completion | 2019-08 |
| Phase | Phase 2 |
What the finished NCT01516307 record still lists
NCT01516307 is an interventional study that assigns participants to a tested intervention. The registered 349 participants enrollment target is mid-sized for trials with a published cap, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (73% higher).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01516307 names 20 study sites across 8 states, led by California, Other, Alabama.
Frequently Asked Questions
What is clinical trial NCT01516307 about?
NCT01516307 is a clinical study titled "Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects". 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.
What is the current status of trial NCT01516307?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 349 participants. The study started on 2011-12. Estimated completion is 2019-08.
What conditions does trial NCT01516307 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT01516307?
The interventions under investigation include: Cyclophosphamide (DRUG), OPT-822/OPT-821(30 μg/100 μg) (BIOLOGICAL), Phosphate Buffer Saline (PBS) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01516307?
This trial is sponsored by OBI Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01516307 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01516307's enrollment target sits among peer trials
349 21st of 139 higher than 119 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer 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.
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