Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Public ClinicalTrials.gov record NCT01140607. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01140607
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2010 (Type not available)
- Primary completion
- Jul 2014 (Actual)
- Completion
- Jul 2014 (Actual)
- Last update posted
- Jul 21, 2015
2010 – 2014
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840014 | La Jolla | California | 92093 | — |
| Investigational Site Number 840013 | Loma Linda | California | 92354 | — |
| Investigational Site Number 840020 | Washington D.C. | District of Columbia | 20037 | — |
| Investigational Site Number 840016 | Jacksonville | Florida | 32207 | — |
| Investigational Site Number 840002 | Tampa | Florida | 33612 | — |
| Investigational Site Number 840017 | Decatur | Illinois | 62526 | — |
| Investigational Site Number 840003 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 840019 | Baltimore | Maryland | 21201 | — |
| Investigational Site Number 840012 | Boston | Massachusetts | 02115 | — |
| Investigational Site Number 840001 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840021 | Canton | Ohio | 44718 | — |
| Investigational Site Number 840007 | Cincinnati | Ohio | 45267-0542 | — |
| Investigational Site Number 840010 | Bethlehem | Pennsylvania | 18015 | — |
| Investigational Site Number 840006 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01140607, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2015 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01140607 live on ClinicalTrials.gov.