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NCT01862900 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Body Radiation and Monoclonal Antibody to OX40 (MEDI6469) in Breast Cancer Patients With Metastatic Lesions
A Phase 1 study, sponsored by Providence Health & Services.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01862900: Completed Phase 1 study, sponsored by Providence Health & Services.
NCT01862900 is a Phase 1 study that has completed, run by Providence Health & Services. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01862900, a Phase 1 study, has completed, sponsored by Providence Health & Services.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with stereotactic body radiation in breast cancer patients that have liver or lung metastases and have received systemic therapy and have progressive disease. The investigators hypothesize that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor immune system response. This amplified and directed immune response could result in anti-tumor responses.
Primary Outcome
A dose limiting toxicity (DLT) is defined as any greater than or equal to grade 3 non-hematologic toxicity (except hypothyroidism or vitiligo) that in the opinion of the investigator is considered at least possibly related to treatment. Grade 3 or 4 hematologic toxicities that take longer than 10 days to resolve will be considered DLTs. Patients will have 8 clinic visits over 36 days to identify toxicities.
Interventions
- BIOLOGICAL MEDI6469
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-04-27 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 1 |
What the finished NCT01862900 record still lists
NCT01862900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which MEDI6469 is the first listed.
NCT01862900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01862900 about?
NCT01862900 is a clinical study titled "Stereotactic Body Radiation and Monoclonal Antibody to OX40 (MEDI6469) in Breast Cancer Patients With Metastatic Lesions". This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with stereotactic body radiation in breast cancer patients that have liver or lung metastases and have received systemic therapy and have progressive disease. The investigators hypothesize that SBRT directed at m...
What is the current status of trial NCT01862900?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-04-27. Estimated completion is 2018-08-15.
What interventions are being tested in trial NCT01862900?
The interventions under investigation include: MEDI6469 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01862900?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01862900's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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