Trial record 1 of 1 for:    POP6792
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Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01140607
First received: May 28, 2010
Last updated: July 20, 2015
Last verified: July 2015

May 28, 2010
July 20, 2015
May 2010
July 2014   (final data collection date for primary outcome measure)
Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: Yes ]
A clinical adverse event or a laboratory abnormality is defined as DLT when it is drug-related as assessed by the investigator and agreed upon by the study committee.
Same as current
Complete list of historical versions of study NCT01140607 on ClinicalTrials.gov Archive Site
  • Safety investigations (physical examination, vital signs and laboratory tests) [ Time Frame: up to 30 days after the last dosing ] [ Designated as safety issue: Yes ]

    Physical examination includes Eastern Cooperative Oncology Group (ECOG) performance status and signs and symptoms.

    Vital signs includes weight, temperature, blood pressure and heart rate.

    Laboratory tests includes hematology, coagulation, biochemistry and urinalysis. Laboratory abnormalities are graded according to the NCI CTCAE v.4.0

  • Pharmacokinetic profile of Cabazitaxel (AUC, Cmax, t1/2, CL, and Vss) from plasma concentration [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: No ]
  • Cabazitaxel effect on CYP3A enzyme activity [ Time Frame: single dosing on day -1 and day 1 ] [ Designated as safety issue: No ]
  • Safety investigations (physical examination, vital signs and laboratory tests) [ Time Frame: up to 30 days after the last dosing ] [ Designated as safety issue: Yes ]

    Physical examination includes Eastern Cooperative Oncology Group (ECOG) performance status and signs and symptoms.

    Vital signs includes weight, temperature, blood pressure and heart rate.

    Laboratory tests includes hematology, coagulation, biochemistry and urinalysis. Laboratory abnormalities are graded according to the NCI CTCAE v.4.0

  • Pharmacokinetic profile of Cabazitaxel (AUC, Cmax, t1/2, CL, and Vss) from plasma concentration [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment

Primary Objectives:

  • To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment
  • To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees of hepatic impairment
  • To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide prescribers with regard to dosing in this patient population
  • To assess the effect of cabazitaxel at recommended dose of 25mg/m^2 on CYP3A enzyme activity using midazolam as probe in an additional cohort of cancer patients with normal hepatic function.

The study consists of:

  • a screening phase (maximum length of 21-day).
  • a treatment phase with 21-day study treatment cycles. Cycle lengths may be extended up to maximum of 12 additional days in case of unresolved toxicity.

Patients continue to receive treatment until they experience, unacceptable toxicities/AEs, disease progression ,withdraw their consent, or the investigator decides to discontinue the patient, or study cut-off, whichever comes first.

  • a 30-day follow-up visit after the last dose of study medication.

The cut off date is when the last patient treated has completed cycle 1 and the subsequent 30 days follow-up.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm Malignant
Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution for infusion

Route of administration: intravenous

  • Experimental: Cohort 1: normal hepatic function: cabazitaxel

    cabazitaxel 25mg/m^2

    IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

    Intervention: Drug: Cabazitaxel (XRP6258)
  • Experimental: Cohort 2: mild hepatic impairment : cabazitaxel

    cabazitaxel 20mg/m^2

    IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

    Intervention: Drug: Cabazitaxel (XRP6258)
  • Experimental: Cohort 3: moderate hepatic impairment: cabazitaxel

    cabazitaxel 10mg/m^2

    IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

    Intervention: Drug: Cabazitaxel (XRP6258)
  • Experimental: Cohort 4: severe hepatic impairment: cabazitaxel

    cabazitaxel 5 mg/m^2 or 10mg/m^2

    IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

    Intervention: Drug: Cabazitaxel (XRP6258)
  • Experimental: Cohort 5: normal hepatic function: cabazitaxel and midazolam

    cabazitaxel 25mg/m^2

    IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

    Midazolam is given orally in single dosing on day -1 and day 1 (crossover)

    Intervention: Drug: Cabazitaxel (XRP6258)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients with a diagnosis of advanced, measurable or non-measurable, non-hematological cancer who have varying degrees of hepatic impairment. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists.

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2
  • Life expectancy <3 months
  • Need for a major surgical procedure or radiation therapy during the study
  • Evidence of another active malignancy
  • Prior chemotherapy, other investigational drug, biological therapy, targeted non-cytotoxic therapy and radiotherapy within 3 weeks prior to registration
  • Patients with known history of Gilbert's syndrome
  • Prior treatment with Cabazitaxel and a history of severe (Grade ≥3) hypersensitivity to taxanes, polysorbate-80, or to compounds with similar chemical structures
  • Prior history of bone marrow transplant
  • Any treatment known to induce CYP isoenzymes or to inhibit CYP3A4 activities within 2 weeks before or during the test period of the pharmacokinetic sampling. Moderate inhibitors within one week prior and during the pharmacokinetic sampling.
  • Any contra-indications to midazolam, according to the applicable labeling.

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

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01140607
POP6792, U1111-1116-5845
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP