Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
This study is currently recruiting participants.
Verified April 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01140607
First received: May 28, 2010
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm Malignant |
Drug: Cabazitaxel (XRP6258) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: Yes ]A clinical adverse event or a laboratory abnormality is defined as DLT when it is drug-related as assessed by the investigator and agreed upon by the study committee.
Secondary Outcome Measures:
- Safety investigations (physical examination, vital signs and laboratory tests) [ Time Frame: up to 30 days after the last dosing ] [ Designated as safety issue: Yes ]
Physical examination includes Eastern Cooperative Oncology Group (ECOG) performance status and signs and symptoms.
Vital signs includes weight, temperature, blood pressure and heart rate.
Laboratory tests includes hematology, coagulation, biochemistry and urinalysis. Laboratory abnormalities are graded according to the NCI CTCAE v.4.0
- Pharmacokinetic profile of Cabazitaxel (AUC, Cmax, t1/2, CL, and Vss) from plasma concentration [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: cabazitaxel
IV infusion is given over 1 hour on Day1 of each cycle (every 3 weeks). |
Drug: Cabazitaxel (XRP6258)
Pharmaceutical form:solution for infusion Route of administration: intravenous |
Detailed Description:
The study consists of:
- a screening phase (maximum length of 21-day).
- a treatment phase with 21-day study treatment cycles. Cycle lengths may be extended up to maximum of 12 additional days in case of unresolved toxicity.
Patients continue to receive treatment until they experience, unacceptable toxicities/AEs, disease progression ,withdraw their consent, or the investigator decides to discontinue the patient, or study cut-off, whichever comes first.
- a 30-day follow-up visit after the last dose of study medication.
The cut off date is when the last patient treated has completed cycle 1 and the subsequent 30 days follow-up.
Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawal criteria.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients with a diagnosis of advanced, measurable or non-measurable, non-hematological cancer who have varying degrees of hepatic impairment. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists.
Exclusion criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2
- Life expectancy <3 months
- Need for a major surgical procedure or radiation therapy during the study
- Evidence of another active malignancy
- Prior chemotherapy, other investigational drug, biological therapy, targeted non-cytotoxic therapy and radiotherapy within 3 weeks prior to registration
- Patients with known history of Gilbert's syndrome
- Prior treatment with Cabazitaxel and a history of severe (Grade ≥3) hypersensitivity to taxanes, polysorbate-80, or to compounds with similar chemical structures
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140607
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
Locations
| United States, California | |
| Investigational Site Number 840013 | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Investigational Site Number 840014 | Recruiting |
| San Francisco, California, United States, 94143 | |
| United States, District of Columbia | |
| Investigational Site Number 840020 | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Investigational Site Number 840016 | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Investigational Site Number 840002 | Completed |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Investigational Site Number 840024 | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Investigational Site Number 840017 | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| United States, Indiana | |
| Investigational Site Number 840022 | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Investigational Site Number 840003 | Recruiting |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| Investigational Site Number 840019 | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Investigational Site Number 840012 | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Investigational Site Number 840004 | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Investigational Site Number 840001 | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Investigational Site Number 840021 | Recruiting |
| Canton, Ohio, United States, 44718 | |
| Investigational Site Number 840007 | Recruiting |
| Cincinnati, Ohio, United States, 45267-0542 | |
| United States, Pennsylvania | |
| Investigational Site Number 840010 | Completed |
| Bethlehem, Pennsylvania, United States, 18015 | |
| United States, Texas | |
| Investigational Site Number 840006 | Recruiting |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01140607 History of Changes |
| Other Study ID Numbers: | POP6792, U1111-1116-5845 |
| Study First Received: | May 28, 2010 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 13, 2013