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

Phase 1
18 Years
Open (Enrolling)
Neoplasm Malignant

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Trial Information

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

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have not met study withdrawn criteria.

Inclusion 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

- 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

- 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

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

Type of Study:


Study Design:

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

Outcome Measure:

Pharmacokinetic profile of cabazitaxel in study population

Outcome Time Frame:

Up to day 10

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:




Start Date:

April 2012

Completion Date:

April 2015

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms