NEWS HIGHLIGHTSMedia Articles Related to Jevtana (Cabazitaxel)
Among Patients Carrying BRCA Mutations, PARP Inhibitor Shows Activity In Pancreatic, Prostate Cancers
Source: Health News from Medical News Today [2013.05.18]
In the largest clinical trial to date to examine the efficacy of PARP inhibitor therapy in BRCA 1/2 carriers with diseases other than breast and ovarian cancer, the oral drug olaparib was found to be effective against advanced pancreatic and prostate cancers. Results of the study, led by researchers from the Perelman School of Medicine at the University of Pennsylvania and Sheba Medical Center in Tel Hashomer, Israel, will be presented during the American Society of Clinical Oncology's annual meeting in Chicago in early June (Abstract #11024)...
Advanced Prostate Cancer Drug Xofigo Approved By FDA
Source: Health News from Medical News Today [2013.05.17]
Xofigo (radium Ra 223 dichloride) has been approved by the US FDA for symptomatic late-stage (metastatic) castration-resistant prostate cancer that has reached bones but not other organs, i.e. with no known visceral metastatic disease. The Food and Drug Administration (FDA) approved Xifogo under the priority review program, three months ahead of schedule. According to an online FDA communiqué published this week, Xofigo is aimed at male patients whose prostate cancer metastasized despite receiving medical or surgical interventions to reduce testosterone levels...
Xofigo Approved for Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.17]
Title: Xofigo Approved for Prostate Cancer
Category: Health News
Created: 5/16/2013 4:36:00 PM
Last Editorial Review: 5/17/2013 12:00:00 AM
Androgen Deprivation Therapy For Prostate Cancer Can Cause Osteoporosis
Source: Bones / Orthopedics News From Medical News Today [2013.05.16]
Androgen deprivation therapy is a common and effective treatment for advanced prostate cancer. However, among other side-effects, it can cause significant bone thinning in men on long-term treatment...
FDA Approves New Drug to Fight Advanced Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.16]
Title: FDA Approves New Drug to Fight Advanced Prostate Cancer
Category: Health News
Created: 5/15/2013 12:36:00 PM
Last Editorial Review: 5/16/2013 12:00:00 AM
Published Studies Related to Jevtana (Cabazitaxel)
TROPIC: Phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. [2011.04]
For patients with metastatic castration-resistant prostate cancer (mCRPC), the current standard of care is chemotherapy involving the tubulin-binding taxane docetaxel. However, as the tumor cells become resistant to docetaxel-based therapy, disease progression is inevitable, and until recently there was no further available treatment beyond palliative care.
Managing side effects of the novel taxane cabazitaxel in castrate-resistant
prostate cancer. [2012]
Cabazitaxel, a novel taxane, was approved in June 2010 by the U.S. Food and Drug
Administration for treatment of metastatic castrate-resistant prostate cancer
(mCRPC) in men previously treated with docetaxel... This article reviews the vital role of nurses in
identifying patients at high risk for AEs associated with cabazitaxel therapy and
reviews strategies for prevention and management of symptoms.
The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment
of hormone-refractory metastatic prostate cancer: summary of the scientific
assessment of the committee for medicinal products for human use. [2012]
On March 17, 2011 the European Commission issued a marketing authorization valid
throughout the European Union for Jevtana® (Sanofi-Aventis, Paris, France) for
the treatment of patients with hormone-refractory metastatic prostate cancer
previously treated with a docetaxel-containing regimen... The detailed scientific assessment report and
product information, including the summary of product characteristics, are
available on the European Medicines Agency Web site (http://www.ema.europa.eu).
Cabazitaxel: a novel microtubule inhibitor. [2011.07.09]
The development of drug resistance is a major obstacle to effective cancer therapy. Several agents are in clinical development with the goal of overcoming resistance... This article presents the preliminary antitumour activity, safety, tolerability and pharmacokinetic data of cabazitaxel, and an overview of the current status of clinical development.
A multicentre dose-escalating study of cabazitaxel (XRP6258) in combination with capecitabine in patients with metastatic breast cancer progressing after anthracycline and taxane treatment: a phase I/II study. [2011.05]
BACKGROUND: Most patients with metastatic breast cancer (MBC) progress after chemotherapy. Cabazitaxel (XRP6258) is a new taxoid that is active in chemotherapy-resistant tumour cell lines. The objectives of this phase I/II study were to assess the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and activity of cabazitaxel plus capecitabine in patients with MBC who had been previously treated with taxanes and anthracyclines... CONCLUSIONS: Cabazitaxel combined with capecitabine is active, has a safety profile consistent with a taxane plus capecitabine combination and warrants further investigation in patients with MBC. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Clinical Trials Related to Jevtana (Cabazitaxel)
Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor [Recruiting]
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 with
gemcitabine, every 3 weeks in patients with advanced solid malignancies.
- Part 2: To determine the antitumor activity of cabazitaxel in combination with
gemcitabine, in an additional extended cohort of 15 patients with advanced solid
malignancies treated with the defined MTD, as assessed by objective response rate (ORR)
according to the revised guideline for Response Evaluation Criteria in Solid Tumours
(RECIST 1. 1 criteria).
Secondary Objectives:
- To assess the safety profile of the combination regimen of cabazitaxel with
gemcitabine.
- To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite,
and 2,2 difluoridine when given in combination.
- To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of
Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the
study and the patients who received the MTD in Part 1 component.
- To assess the potential inhibitory effect of cabazitaxel on CYP3A4 using midazolam, a
CYP3A4 probe since cabazitaxel inhibits CYP3A4 in vitro.
Cabazitaxel - PF Induction Chemotherapy [Recruiting]
The primary objective of this study is to determine the first-cycle maximum tolerated dose
(MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and
Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma
of the head and neck for three cycles.
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer [Recruiting]
Lung cancer is the leading cause of cancer death worldwide and in the United States. The
majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases
are advanced at the time of diagnosis. Chemotherapy has improved overall survival but
remains limited at < 12 months median overall survival. New approaches are needed for second
line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in
metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.
Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer [Recruiting]
This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with
concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation
therapy that uses computer-generated images to show the size and shape of the tumor. Thin
beams of radiation of different intensities are aimed at the tumor from many angles.) and
androgen deprivation therapy (Treatment to suppress or block the production or action of
male hormones) in patients with locally advanced prostate cancer.
It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control
can be achieved and eventually the cure rate can be increased. After this study, the
maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can
be found.
Men with locally advanced high risk prostate cancer represent a group of patients for whom
cure is potentially achievable utilizing a multimodality approach. More aggressive treatment
upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize
that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel
approach will improve disease control and eventually improve survival for locally advanced
prostate cancer patients.
Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer [Not yet recruiting]
Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in
patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this
study is to better understand the response and toxicity of cabazitaxel of elderly men (age
75 years and older) with advanced prostate cancer who have progressed during or after
treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous
(through a vein) infusion plus prednisone by mouth twice daily, and following the
chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF).
G-CSF will help the body produce more white blood cells, which should help decrease the risk
of getting an infection while being treated with cabazitaxel.
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