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

Completed · Phase 1

Conditions studied: Solid Cancer

In brief

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.

Key facts

Study ID

NCT00925743

Run by

Sanofi

People needed

76

Starts

2009-06-01

Expected to finish

2013-03-01

Last updated by the study team

2013-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.