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NCT01140607 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01140607 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 56 participants.
The verdict
NCT01140607, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
Primary Objectives: * To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment * To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees of hepatic impairment * To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide prescribers with regard to dosing in this patient population * To assess the effect of cabazitaxel at recommended dose of 25mg/m\^2 on CYP3A enzyme activity using midazolam as probe in an additional cohort of cancer patients with normal hepatic function.
Interventions
- DRUG Cabazitaxel (XRP6258)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01140607
The ClinicalTrials.gov registry entry for NCT01140607 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cabazitaxel (XRP6258) is the first listed.
NCT01140607 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01140607 about?
NCT01140607 is a clinical study titled "Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment". Primary Objectives: * To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment * To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees of hepatic impairment...
What is the current status of trial NCT01140607?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2010-05. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01140607?
The interventions under investigation include: Cabazitaxel (XRP6258) (DRUG).
Who is sponsoring clinical trial NCT01140607?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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