Advertisement

Topics

Effect of Cabazitaxel on the QTc Interval in Cancer Patients

2014-08-27 03:15:12 | BioPortfolio

Summary

Primary Objective:

- To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients

Secondary Objectives:

- To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals

- To assess the clinical safety of cabazitaxel

- To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)

Description

The main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).

After Cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Neoplasms, Malignant

Intervention

Cabazitaxel (XRP6258)

Location

Sanofi-Aventis Investigational Site Number 840006
San Diego
California
United States
92103

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:12-0400

Clinical Trials [722 Associated Clinical Trials listed on BioPortfolio]

Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment

Primary Objectives: - To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic ...

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

The purpose of this study is to evaluate the safety and dosing of cabazitaxel with cisplatin given every 3 weeks in patients with advanced solid cancer. Other objectives of this study is ...

Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor

Primary Objectives: - Part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination...

Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

Primary Objective: To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer Secondary Objectives: 1. To describe the ...

Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer

Primary Objectives: - To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with ora...

PubMed Articles [2097 Associated PubMed Articles listed on BioPortfolio]

MR Imaging of Pleural Neoplasms.

The pleura may be affected by primary tumors or metastatic spread of intrathoracic or extrathoracic neoplasms. Primary pleural neoplasms represent ∼10% of all pleural tumors, and malignant lesions a...

Observational, multicenter study of cabazitaxel in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (CAPRISTANA).

To obtain routine clinical practice data on cabazitaxel usage patterns for patients with metastatic castration-resistant prostate cancer (mCRPC) and to describe physician-assessed cabazitaxel effectiv...

The Diagnosis of Pleural Tumors Other Than Mesothelioma.

- Pleural pathology has been dominated by discussions relating to the diagnosis, prognosis, etiology, and management of malignant mesothelioma. However, there exists a diverse group of other neoplasms...

Indirect treatment comparison of cabazitaxel for patients with metastatic castrate-resistant prostate cancer who have been previously treated with a docetaxel-containing regimen.

The objective of this study was to conduct an indirect treatment comparison between cabazitaxel, abiraterone and enzalutamide to determine the clinical efficacy and safety of cabazitaxel relative to c...

Malignant proliferating trichilemmal tumour.

Proliferating trichilemmal tumours are benign but locally aggressive skin neoplasms arising from hair follicles. Rarely, they can become malignant and must be appropriately managed to prevent recurren...

Medical and Biotech [MESH] Definitions

New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Benign and malignant neoplasms which occur within the substance of the spinal cord (intramedullary neoplasms) or in the space between the dura and spinal cord (intradural extramedullary neoplasms). The majority of intramedullary spinal tumors are primary CNS neoplasms including ASTROCYTOMA; EPENDYMOMA; and LIPOMA. Intramedullary neoplasms are often associated with SYRINGOMYELIA. The most frequent histologic types of intradural-extramedullary tumors are MENINGIOMA and NEUROFIBROMA.

Distinctive neoplastic disorders of histiocytes. Included are malignant neoplasms of MACROPHAGES and DENDRITIC CELLS.

Neoplasms which arise from peripheral nerve tissue. This includes NEUROFIBROMAS; SCHWANNOMAS; GRANULAR CELL TUMORS; and malignant peripheral NERVE SHEATH NEOPLASMS. (From DeVita Jr et al., Cancer: Principles and Practice of Oncology, 5th ed, pp1750-1)

Benign and malignant neoplasms that arise from one or more of the twelve cranial nerves.

More From BioPortfolio on "Effect of Cabazitaxel on the QTc Interval in Cancer Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...


Searches Linking to this Trial