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

Phase 1

Completed

• Conditions: Solid Cancer
• Interventions: Drug: cabazitaxel (XRP6258)

• Registration Number: NCT00925743
• Lead Sponsor: Sanofi

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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	cabazitaxel (XRP6258)	* 5, 15, 20 or 25 mg/m2 * one injection of cabazitaxel on day 1 of each cycle (3 weeks)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to progression (TTP) (part 1 and 2)	up to 6 cycles, ie 18 weeks
Duration of response (DR) (Part 1 and 2)	up to 6 cycles, ie 18 weeks
Cabazitaxel pharmacokinetic (part 1 and 2)	up to 6 cycles, ie 18 weeks

Trial Locations

Locations (7)

Investigational Site Number 840002; 🇺🇸 Baltimore, Maryland, United States

Investigational Site Number 840010; 🇺🇸 Decatur, Illinois, United States

Investigational Site Number 840003; 🇺🇸 San Diego, California, United States

Investigational Site Number 840007; 🇺🇸 Cincinnati, Ohio, United States

Investigational Site Number 840005; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 840008; 🇺🇸 Los Angeles, California, United States

Investigational Site Number 840006; 🇺🇸 St Louis, Missouri, United States