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Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasm Malignant

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Trial Information

Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment


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.

Inclusion Criteria


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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of Dose Limiting Toxicities (DLT)

Outcome Description:

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.

Outcome Time Frame:

cycle 1 (3 weeks)

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

POP6792

NCT ID:

NCT01140607

Start Date:

May 2010

Completion Date:

May 2014

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms

Name

Location

Investigational Site Number 840007Cincinnati, Ohio  45267-0542
Investigational Site Number 840013Loma Linda, California  92354
Investigational Site Number 840014San Francisco, California  94143
Investigational Site Number 840020Washington, District of Columbia  20037
Investigational Site Number 840016Jacksonville, Florida  32207
Investigational Site Number 840002Tampa, Florida  33612
Investigational Site Number 840017Decatur, Illinois  62526
Investigational Site Number 840003Metairie, Louisiana  70006
Investigational Site Number 840019Baltimore, Maryland  21201
Investigational Site Number 840012Boston, Massachusetts  02115
Investigational Site Number 840001St Louis, Missouri  63110
Investigational Site Number 840021Canton, Ohio  44718
Investigational Site Number 840010Bethlehem, Pennsylvania  18015
Investigational Site Number 840006San Antonio, Texas  78229
Investigational Site Number 840024Augusta, Georgia  30912
Investigational Site Number 840022Indianapolis, Indiana  46202
Investigational Site Number 840004Detroit, Michigan  48201