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NCT01087021 · ClinicalTrials.gov registry record · Phase 1
Effect of Cabazitaxel on the QTc Interval in Cancer Patients
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01087021: Completed Phase 1 study, sponsored by Sanofi.
NCT01087021 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087021, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
Primary Objective: * To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: * To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals * To assess the clinical safety of cabazitaxel * To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)
Interventions
- DRUG Cabazitaxel (XRP6258)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01087021 record still lists
NCT01087021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Cabazitaxel (XRP6258) is the first listed.
NCT01087021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01087021 about?
NCT01087021 is a clinical study titled "Effect of Cabazitaxel on the QTc Interval in Cancer Patients". Primary Objective: * To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: * To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals * To assess ...
What is the current status of trial NCT01087021?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2010-03. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01087021?
The interventions under investigation include: Cabazitaxel (XRP6258) (DRUG).
Who is sponsoring clinical trial NCT01087021?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01087021's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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