Status:
COMPLETED
Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment
Lead Sponsor:
Sanofi
Conditions:
Neoplasm Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 patien...
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 u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01527929
Start Date
April 1 2012
End Date
November 1 2013
Last Update
December 4 2013
Active Locations (7)
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1
Investigational Site Number 056002
Brussels, Belgium, 1200
2
Investigational Site Number 056001
Ghent, Belgium, 9000
3
Investigational Site Number 380001
Milan, Italy, 20133
4
Investigational Site Number 528001
Rotterdam, Netherlands, 3075 EA