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NCT00637897 · ClinicalTrials.gov registry record · Phase 1
Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00637897: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT00637897 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00637897, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more sensitive to the drugs. PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and to see how well it works when given together with chemotherapy in treating patients with metastatic breast cancer.
Primary Outcome
To test the clinical/logistical feasibility of using a titrated dose of the vitamin D analog (paracalcitol or Zemplar) in combination with a taxane or ixabepilone primarily by measuring the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose
Interventions
- DRUG docetaxel
- DRUG paclitaxel
- DRUG paclitaxel albumin-stabilized nanoparticle formulation
- DRUG ixabepilone
- DRUG paricalcitol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-03 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT00637897 record still lists
NCT00637897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which docetaxel is the first listed.
NCT00637897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00637897 about?
NCT00637897 is a clinical study titled "Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paricalcitol may help chemotherapy d...
What is the current status of trial NCT00637897?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-03. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00637897?
The interventions under investigation include: docetaxel (DRUG), paclitaxel (DRUG), paclitaxel albumin-stabilized nanoparticle formulation (DRUG), ixabepilone (DRUG), paricalcitol (DRUG).
Who is sponsoring clinical trial NCT00637897?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00637897's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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