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NCT02502864 · ClinicalTrials.gov registry record · Phase 4
Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide
A Phase 4 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT02502864: Completed Phase 4 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02502864 is a Phase 4 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02502864, a Phase 4 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood. This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of docetaxel using this method will lessen the side effects associated with docetaxel in cancer treatment.
Primary Outcome
Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg\*hr/L) within 4 cycles of therapy in patients \> 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.
Interventions
- DRUG Standard of Care: Docetaxel
- DRUG Standard of Care: Cyclophosphamide
- OTHER Function Assessment of Cancer Therapy (FACT) Surveys
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-02-09 |
| Est. Completion | 2019-01-31 |
| Phase | Phase 4 |
What the finished NCT02502864 record still lists
NCT02502864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of Care: Docetaxel is the first listed.
NCT02502864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02502864 about?
NCT02502864 is a clinical study titled "Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide". The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood. This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of docetaxel using this metho...
What is the current status of trial NCT02502864?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2016-02-09. Estimated completion is 2019-01-31.
What interventions are being tested in trial NCT02502864?
The interventions under investigation include: Standard of Care: Docetaxel (DRUG), Standard of Care: Cyclophosphamide (DRUG), Function Assessment of Cancer Therapy (FACT) Surveys (OTHER).
Who is sponsoring clinical trial NCT02502864?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02502864's enrollment target sits among peer trials
9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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