Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Cancer

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)

Outcome Time Frame:

first cycle (i.e.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:

TCD10870

NCT ID:

NCT00925743

Start Date:

June 2009

Completion Date:

March 2013

Related Keywords:

  • Solid Cancer
  • Phase 1
  • XRP6258
  • cisplatin
  • Antineoplastic Combined Chemotherapy Protocols

Name

Location

Investigational Site Number 840010Naperville, Illinois  60540
Investigational Site Number 840008Los Angeles, California  90048
Investigational Site Number 840003San Diego, California  92123
Investigational Site Number 840002Baltimore, Maryland  21201
Investigational Site Number 840006St Louis, Missouri  63110
Investigational Site Number 840007Cincinnati, Ohio  45267-0542
Investigational Site Number 840005San Antonio, Texas  78229