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NCT03562637 · ClinicalTrials.gov registry record · Phase 3
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
A Phase 3 study of Triple Negative Breast Cancer, sponsored by OBI Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 575
- Enrollment target
- 20
- Study locations
NCT03562637 is a Phase 3 study of Triple Negative Breast Cancer that is active but no longer recruiting, run by OBI Pharma. The registered enrollment target is 575 participants, above the 242-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT03562637, a Phase 3 study of Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by OBI Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 575 participants
- Enrollment target
- 20
- Study locations
Study Summary
The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.
Conditions Studied
Interventions
- OTHER Standard of care treatment
- BIOLOGICAL adagloxad simolenin combined with OBI-821
- DEVICE Globo H IHC Assay
Study Locations (20)
California
- Moores UCSD Cancer Center - La Jolla
- Kaiser Permanente Medical Center - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Centre - San Francisco
Other
- St Vincent's Hospital Sydney - Darlinghurst
- Gosford Hospital - Gosford
- St John of God Murdoch Hospital - Murdoch
Victoria
- Victoria Breast & Oncology Care - East Melbourne
- Cabrini Malvern - Malvern
Florida
- Miami Cancer Institute - Miami
Illinois
- University of Chicago Medical - Chicago
Maryland
- University of Maryland Greenbaum Comprehensive Cancer Center - Baltimore
Michigan
- Henry Ford Medical Center - Detroit
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03562637
The ClinicalTrials.gov registry entry for NCT03562637 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 242-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (138% higher). The listed sponsor is OBI Pharma, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Standard of care treatment is the first listed.
NCT03562637 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Other, Victoria.
Frequently Asked Questions
What is clinical trial NCT03562637 about?
NCT03562637 is a clinical study titled "Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC". The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.
What is the current status of trial NCT03562637?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 575 participants. The study started on 2018-12-05. Estimated completion is 2027-12-30.
What conditions does trial NCT03562637 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT03562637?
The interventions under investigation include: Standard of care treatment (OTHER), adagloxad simolenin combined with OBI-821 (BIOLOGICAL), Globo H IHC Assay (DEVICE).
Who is sponsoring clinical trial NCT03562637?
This trial is sponsored by OBI Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03562637 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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