A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00925743
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : May 16, 2013
Information provided by (Responsible Party):

Brief Summary:

This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).

There are 4 parts to the study:

Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.

Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.

Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.

Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.

Condition or disease Intervention/treatment Phase
Solid Cancer Drug: cabazitaxel (XRP6258) Phase 1

Detailed Description:

The total duration on the study per subject will be about 26 weeks broken down as follows:

  • A maximum of 21-day screening phase,
  • 21-days (+/- 2 weeks) study treatment cycles,
  • 30-day follow-up visit after the last dose of study medication.
  • Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.

Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
Study Start Date : June 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
  • 5, 15, 20 or 25 mg/m2
  • one injection of cabazitaxel on day 1 of each cycle (3 weeks)
Drug: cabazitaxel (XRP6258)
  • administered by IV infusion
  • in addition to cisplatin treatment

Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1) [ Time Frame: first cycle (i.e.3 weeks) ]
  2. Objective response ratio (Complete response (CR) and partial response (PR)) (part 2) [ Time Frame: up to 6 cycles, ie 18 weeks ]
  3. Pharmacokinetics (PK) of cabazitaxel (part 3 and 4) [ Time Frame: up to 6 cycles, ie 18 weeks ]

Secondary Outcome Measures :
  1. Time to progression (TTP) (part 1 and 2) [ Time Frame: up to 6 cycles, ie 18 weeks ]
  2. Duration of response (DR) (Part 1 and 2) [ Time Frame: up to 6 cycles, ie 18 weeks ]
  3. Cabazitaxel pharmacokinetic (part 1 and 2) [ Time Frame: up to 6 cycles, ie 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
  • signed informed consent

Exclusion criteria

  • limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
  • inability to follow study requirements and schedule
  • treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
  • serious medical illness at same time of study and/or significantly abnormal lab reports
  • lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
  • Women of childbearing potential not protected by highly effective contraceptive method of birth control OTHER than hormonal contraception (Part 4 only).
  • prior significant hearing or kidney problems
  • continued toxic effects of prior chemotherapy
  • cancers that cannot be physically measured (Part 2 only)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925743

United States, California
Investigational Site Number 840008
Los Angeles, California, United States, 90048
Investigational Site Number 840003
San Diego, California, United States, 92123
United States, Illinois
Investigational Site Number 840010
Decatur, Illinois, United States, 62526
United States, Maryland
Investigational Site Number 840002
Baltimore, Maryland, United States, 21201
United States, Missouri
Investigational Site Number 840006
St Louis, Missouri, United States, 63110
United States, Ohio
Investigational Site Number 840007
Cincinnati, Ohio, United States, 45267-0542
United States, Texas
Investigational Site Number 840005
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00925743     History of Changes
Other Study ID Numbers: TCD10870
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013

Keywords provided by Sanofi:
Phase 1
Antineoplastic Combined Chemotherapy Protocols

Additional relevant MeSH terms:
Antineoplastic Agents