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NCT01997333 · ClinicalTrials.gov registry record · Phase 2
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
A Phase 2 study of Metastatic gpNMB Over-expressing Triple Negative Breast Cancer, sponsored by Celldex Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 327
- Enrollment target
- 20
- Study locations
NCT01997333: Completed Phase 2 study of Metastatic gpNMB Over-expressing Triple Negative Breast Cancer, sponsored by Celldex Therapeutics.
NCT01997333 is a Phase 2 study of Metastatic gpNMB Over-expressing Triple Negative Breast Cancer that has completed, run by Celldex Therapeutics. The registered enrollment target is 327 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (146% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01997333, a Phase 2 study of Metastatic gpNMB Over-expressing Triple Negative Breast Cancer, has completed, sponsored by Celldex Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 327 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
Primary Outcome
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to tre
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG CDX-011
Study Locations (20)
California
- Compassionate Care Research Group - Fountain Valley
- St. Jude Heritage Medical Group - Fullerton
- USC Norris Comprehensive Cancer Center and Hospital - Los Angeles
- University of California Davis Medical Center - Sacramento
- Pacific Cancer Care - Salinas
- University of California San Francisco - San Francisco
- Kaiser Permaente - Vallejo
- Wellness Hematology Oncology - West Hills
Florida
- University of Miami Miller School of Medicine - Deerfield Beach
- Florida Cancer Specialists South - Fort Myers
- Memorial Regional Hospital - Hollywood
- Baptist Cancer Institute - Jacksonville
- Florida Cancer Specialists - New Port Richey
- Tallahassee Memorial HealthCare - Tallahassee
Alabama
- Alabama Oncology - Birmingham
- University of Alabama at Birmingham - Birmingham
- University of South Alabama Cancer Research Insititute - Mobile
Arizona
- Arizona Cancer Research Alliance - Glendale
- Arizona Cancer Center - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-08-07 |
| Phase | Phase 2 |
What the finished NCT01997333 record still lists
NCT01997333 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (146% higher).
The record links to 1 condition, with Metastatic gpNMB Over-expressing Triple Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.
NCT01997333 names 20 study sites across 5 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01997333 about?
NCT01997333 is a clinical study titled "Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer". The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The stu...
What is the current status of trial NCT01997333?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 327 participants. The study started on 2013-11. Estimated completion is 2018-08-07.
What conditions does trial NCT01997333 study?
This clinical trial studies the following conditions: Metastatic gpNMB Over-expressing Triple Negative Breast Cancer.
What interventions are being tested in trial NCT01997333?
The interventions under investigation include: Capecitabine (DRUG), CDX-011 (DRUG).
Who is sponsoring clinical trial NCT01997333?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01997333 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01997333's enrollment target sits among peer trials
327 146th of 2000 higher than 1,854 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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