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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00925743
First received: June 19, 2009
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Solid Cancer
Drug: cabazitaxel (XRP6258)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1) [ Time Frame: first cycle (i.e.3 weeks) ] [ Designated as safety issue: Yes ]
  • Objective response ratio (Complete response (CR) and partial response (PR)) (part 2) [ Time Frame: up to 6 cycles, ie 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK) of cabazitaxel (part 3 and 4) [ Time Frame: up to 6 cycles, ie 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression (TTP) (part 1 and 2) [ Time Frame: up to 6 cycles, ie 18 weeks ] [ Designated as safety issue: No ]
  • Duration of response (DR) (Part 1 and 2) [ Time Frame: up to 6 cycles, ie 18 weeks ] [ Designated as safety issue: No ]
  • Cabazitaxel pharmacokinetic (part 1 and 2) [ Time Frame: up to 6 cycles, ie 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: June 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925743

Locations
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
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00925743     History of Changes
Other Study ID Numbers: TCD10870
Study First Received: June 19, 2009
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Phase 1
XRP6258
cisplatin
Antineoplastic Combined Chemotherapy Protocols

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014