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NCT02030964 · ClinicalTrials.gov registry record · Phase 1
N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan
A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02030964 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 30 participants.
The verdict
NCT02030964, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV chemotherapy medicines called cyclophosphamide and topotecan. * To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and topotecan without causing severe side effects. * To find out the side effects seen by giving DFMO at different dose levels with celecoxib, cyclophosphamide and topotecan. * To measure the levels of DFMO in the blood at different dose levels. * To determine if your tumor gets smaller after treatment with DFMO, celecoxib, cyclophosphamide and topotecan. * To determine if specific gene changes in you or your tumor makes you more prone to side effects or affects your tumor's response to the combination of DFMO, celecoxib, cyclophosphamide and topotecan. * To determine if the amount of normal chemicals in your body called polyamines go down in response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more likely to have a good response to the treatment if they do.
Interventions
- DRUG Cyclophosphamide
- DRUG DFMO
- DRUG Celecoxib
- DRUG Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-01-16 |
| Est. Completion | 2023-12-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02030964
The ClinicalTrials.gov registry entry for NCT02030964 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02030964 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02030964 about?
NCT02030964 is a clinical study titled "N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan". This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV chemotherapy medicines called cyclophosphamide and topotecan. * To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and topotecan without causing severe side effects. * To find out...
What is the current status of trial NCT02030964?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-01-16. Estimated completion is 2023-12-30.
What interventions are being tested in trial NCT02030964?
The interventions under investigation include: Cyclophosphamide (DRUG), DFMO (DRUG), Celecoxib (DRUG), Topotecan (DRUG).
Who is sponsoring clinical trial NCT02030964?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
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