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

Solid Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925743
• Other study ID #: TCD10870
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2009
• Last updated: May 15, 2013
• Start date: June 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Solid Cancer

Intervention

Drug:
• cabazitaxel (XRP6258)
administered by IV infusion in addition to cisplatin treatment

Locations

Country	Name	City	State
United States	Investigational Site Number 840002	Baltimore	Maryland
United States	Investigational Site Number 840007	Cincinnati	Ohio
United States	Investigational Site Number 840010	Decatur	Illinois
United States	Investigational Site Number 840008	Los Angeles	California
United States	Investigational Site Number 840005	San Antonio	Texas
United States	Investigational Site Number 840003	San Diego	California
United States	Investigational Site Number 840006	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)		first cycle (i.e.3 weeks)	Yes
Primary	Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)		up to 6 cycles, ie 18 weeks	No
Primary	Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)		up to 6 cycles, ie 18 weeks	No
Secondary	Time to progression (TTP) (part 1 and 2)		up to 6 cycles, ie 18 weeks	No
Secondary	Duration of response (DR) (Part 1 and 2)		up to 6 cycles, ie 18 weeks	No
Secondary	Cabazitaxel pharmacokinetic (part 1 and 2)		up to 6 cycles, ie 18 weeks	No