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

NCT ID: NCT01527929

Last Updated: 2013-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-11-30

Brief 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

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Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.

Conditions

Neoplasm Malignant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Normal renal function - Cabazitaxel administered once every 3 weeks

Group Type: EXPERIMENTAL

Cabazitaxel XRP6258

Intervention Type: DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Cohort B

Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks

Group Type: EXPERIMENTAL

Cabazitaxel XRP6258

Intervention Type: DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Cohort C

Severe renal dysfunction - Cabazitaxel administered once every 3 weeks

Group Type: EXPERIMENTAL

Cabazitaxel XRP6258

Intervention Type: DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Interventions

Cabazitaxel XRP6258

Pharmaceutical form: solution for infusion Route of administration: intravenous

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 056002

Brussels, , Belgium

Investigational Site Number 056001

Ghent, , Belgium

Investigational Site Number 380001

Milan, , Italy

Investigational Site Number 528001

Rotterdam, , Netherlands

Investigational Site Number 528002

Utrecht, , Netherlands

Investigational Site Number 724001

Barcelona, , Spain

Investigational Site Number 826001

Cambridge, , United Kingdom

Countries

Belgium; Italy; Netherlands; Spain; United Kingdom

Other Identifiers

2011-001517-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1121-4512

Identifier Type: OTHER

Identifier Source: secondary_id

POP12251

Identifier Type: -

Identifier Source: org_study_id