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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cisplatin

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.