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NCT01421017 · ClinicalTrials.gov registry record · Phase 1
Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases
A Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01421017: Completed Phase 1 study, sponsored by NYU Langone Health.
NCT01421017 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421017, a Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and test the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and radiotherapy (RT) in patients with skin metastases from breast cancer in the second part (Phase II). Currently this trial is in its Phase II part.
Primary Outcome
The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).
Interventions
- DRUG Cyclophosphamide
- RADIATION Radiation
- DRUG Imiquimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-08-19 |
| Est. Completion | 2016-08-06 |
| Phase | Phase 1 |
What the finished NCT01421017 record still lists
NCT01421017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01421017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421017 about?
NCT01421017 is a clinical study titled "Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases". This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and test the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and radiotherapy (RT) in patients with skin metastases from breast cancer in the second part (Phase II). Currently this trial i...
What is the current status of trial NCT01421017?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2011-08-19. Estimated completion is 2016-08-06.
What interventions are being tested in trial NCT01421017?
The interventions under investigation include: Cyclophosphamide (DRUG), Radiation (RADIATION), Imiquimod (DRUG).
Who is sponsoring clinical trial NCT01421017?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421017's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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