Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment

Neoplasm Malignant Clinical Trial

Official title:

An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527929
• Other study ID #: POP12251
• Secondary ID: 2011-001517-14U1
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2012
• Last updated: December 3, 2013
• Start date: April 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel

Secondary Objective:

• To assess the safety of cabazitaxel in patients with various degrees of renal impairment

Description:

The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.

Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.

• Eastern Cooperative Oncology Group performance status 0 - 2

• Stable renal function

• Patients must have adequate liver and marrow function as defined below:

• Absolute neutrophil count = 1.5x10^9/L

• Platelets = 100x10^9/L

• Total bilirubin = 1.0 x the institutions upper limit of normal

• AST (SGOT)/ALT (SGPT) = 2.5 x the institutions upper limit of normal

• Alkaline phosphatase = 2.5 x the institutions upper limit of normal

• Patient may have a Grade 1 or less neurotoxicity at study entry.

• Life expectancy > 3 months

• Age = 18 years old

• If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.

• Having given written informed consent prior to any procedure related to the study

Exclusion criteria:

• Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to = 30% of bone marrow are not allowed.

• Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack.

• Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.

• Active hepatitis

• Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.

• Patients requiring dialysis during the study.

• History of hypersensitivity to docetaxel or polysorbate 80.

• Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.

• Known brain metastases.

• If female, pregnancy or breast-feeding.

• Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Drug:
• Cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056002	Bruxelles
Belgium	Investigational Site Number 056001	Gent
Italy	Investigational Site Number 380001	Milano
Netherlands	Investigational Site Number 528001	Rotterdam
Netherlands	Investigational Site Number 528002	Utrecht
Spain	Investigational Site Number 724001	Barcelona
United Kingdom	Investigational Site Number 826001	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of cabazitaxel in study population		Up to day 10	No
Secondary	Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters		up to 30 days after the last dosing	No