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

NCT01527929 | Completed Phase 1

• 3 other identifiers: POP122512011-001517-14U1111-1121-4512
• Study Type: interventional
• Target: 25
• Locations: 5 countries
• Sites: 7

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

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of cabazitaxel in study population

  Up to day 10

Secondary Outcomes (1)

• 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

Study Arms (3)

Cohort A

EXPERIMENTAL

Normal renal function - Cabazitaxel administered once every 3 weeks

Drug: Cabazitaxel XRP6258

Cohort B

EXPERIMENTAL

Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks

Drug: Cabazitaxel XRP6258

Cohort C

EXPERIMENTAL

Severe renal dysfunction - Cabazitaxel administered once every 3 weeks

Drug: Cabazitaxel XRP6258

Interventions

Cabazitaxel XRP6258 DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Investigational Site Number 056002

Brussels, 1200, Belgium

Location

Investigational Site Number 056001

Ghent, 9000, Belgium

Location

Investigational Site Number 380001

Milan, 20133, Italy

Location

Investigational Site Number 528001

Rotterdam, 3075 EA, Netherlands

Location

Investigational Site Number 528002

Utrecht, 3584 CX, Netherlands

Location

Investigational Site Number 724001

Barcelona, 08035, Spain

Location

Investigational Site Number 826001

Cambridge, CB2 2QQ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

ES (1); GB (1); IT (1); NL (2); BE (2)