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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01527929
First received: February 2, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Neoplasm Malignant
Drug: Cabazitaxel XRP6258
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pharmacokinetic profile of cabazitaxel in study population [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters [ Time Frame: up to 30 days after the last dosing ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Normal renal function - Cabazitaxel administered once every 3 weeks
Drug: Cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous
Experimental: Cohort B
Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks
Drug: Cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous
Experimental: Cohort C
Severe renal dysfunction - Cabazitaxel administered once every 3 weeks
Drug: Cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527929

Locations
Belgium
Investigational Site Number 056002
Bruxelles, Belgium, 1200
Investigational Site Number 056001
Gent, Belgium, 9000
Italy
Investigational Site Number 380001
Milano, Italy, 20133
Netherlands
Investigational Site Number 528001
Rotterdam, Netherlands, 3075 EA
Investigational Site Number 528002
Utrecht, Netherlands, 3584 CX
Spain
Investigational Site Number 724001
Barcelona, Spain, 08035
United Kingdom
Investigational Site Number 826001
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01527929     History of Changes
Other Study ID Numbers: POP12251, 2011-001517-14, U1111-1121-4512
Study First Received: February 2, 2012
Last Updated: December 3, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014