Xtandi Clinical Trial

Triple-negative Breast Cancer - Wikipedia, The Free Encyclopedia
Triple-negative breast cancer (sometimes abbreviated TNBC) refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. [1] ... Read Article

HIGHLIGHTS OF PRESCRIBING INFORMATION These Highlights Do Not ...
There is no clinical trial experience with XTANDI in patients who have had a seizure, in patients with predisposing factors for seizure, or in patients using concomitant medications that may lower the seizure threshold. (5.1) ... Return Doc

Opposing Views On Medivation News And Xtandi
Medivation, Inc. (NASDAQ: MDVN) was not having a great day on Wednesday. Its shares were seen down 5% or so at $33.10 shortly before the close. News was out on Tuesday signaling that the Journal of Clinical ... Read News

AusPAR Attachment 1. Product Information For Enzalutamide
Attachment 1: Product information for AusPAR Xtandi Enzalutamide Astellas Pharma Australia Pty Ltd PM-2013-01155-1-4 Date of (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhoea, arthralgia, hot flush, peripheral edema ... Read Document

Carcinoma Della Prostata - Wikipedia
Sturgeon CM, Duffy MJ, Stenman UH, et al., National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers, ... Read Article

Pan-Canadian Oncology Drug Review Final Clinical Guidance ...
Pan-Canadian Oncology Drug Review . Final Clinical Guidance Report . Enzalutamide (Xtandi) for Metastatic Castration-Resistant Prostate Cancer . July 23, 2013 ... Doc Viewer

Dr. Neal Shore Discusses The Enzalutamide (MDV3100) AFFIRM Trial
Neal D. Shore, MD, Managing Partner, Atlantic Urology Clinics, Director, CPI, Carolina Urologic Research Center, discusses findings from the phase III AFFIRM trial that examined the new agent enzalutamide (formally MDV3100) for patients with castration-resistant prostate cancer who ... View Video

Pan-Canadian Oncology Drug Review Final Clinical Guidance ...
Pan-Canadian Oncology Drug Review . Final Clinical Guidance Report . Enzalutamide (Xtandi) for First-Line Metastatic Castration-Resistant Prostate ... Retrieve Full Source

FOR IMMEDIATE RELEASE New England Journal Of ...
Increased risk. Seizure risk may be dose dependent with a greater risk at daily doses higher than 160 mg. There is no clinical trial experience re-administering XTANDI to patients ... Document Viewer

Version 1.1 May 2014 - Stampedetrial.org
Storage: Store Xtandi capsules at 20 C to 25 C in a dry place and keep the container tightly closed. Excursion permitted from 15 C to 30 C Patient ID: FOR CLINICAL TRIAL USE ONLY . Title: For Clinical Trial Use Only Author: Any User ... View Full Source

Coping With Loss Of Appetite (Anorexia) With Cancer
What causes loss of appetite (anorexia) with cancer, what are some treatments, and how can you cope with this too common condition? ... Read Article

Clinical Pharmacokinetic Studies Of Enzalutamide
Clinical Pharmacokinetic Studies of Enzalutamide (Xtandi , Astellas Pharma US, Inc., Northbrook, IL, USA, in the intent-to-treat population in the phase III clinical trial (AFFIRM) [2]. Exposure was based on time-averaged steady-state ... Return Document

Abiraterone Monograph
In the clinical trial, one death was associated with arrhythmia, Abiraterone Monograph Updated version may be found at www.pbm.va.gov or vaww.pbm.va.gov 12 STRICTLY CONFIDENTIAL PRE-DECISIONAL DELIBERATION INFORMATION Insert Generic Drug Name Here Monograph ... Get Content Here

Reactions Roundtable Oncology Conference Insight March 2014 ...
Reactions Roundtable Oncology Conference Insight March 2014 Volume 10, Issue 2 Kantar Health discusses the pivotal clinical trials presented at the 2014 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) potentially stronger benefit in the Xtandi trial) ... Retrieve Document

Quick Look Inside
Quick Look Inside Hours of Operation and Room Locations XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration- Warnings and Precautions In the randomized clinical trial, ... Get Document

New England Journal Of Medicine Publishes Results From Phase ...
New England Journal of Medicine Publishes Results from Phase 3 AFFIRM Trial of Enzalutamide -Study appears in August 15 online edition- San Francisco, CA and Tokyo – August 15, 2012 – Medivation integrating clinical observations and basic research to significantly improve patient outcomes ... Content Retrieval

Guidance For Industry - Food And Drug Administration
Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials Additional copies of this guidance are available from the Office of Communication, Training and ... Document Viewer

Health Canada Approves New Indication For The Use Of Xtandi ...
Health Canada Approves New Indication for the Use of Xtandi® (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer . placebo-controlled, multinational clinical trial that enrolled 1,717 chemotherapy - ... Return Document

MEETING PROGRAM - AUA2014
Meeting Program Colors: CMYK Creative + Live-Trim-Bleed: DO NOT PRINT Bleed: 17"w x 12.125"h Trim: 16.25"w x 10.875"h Live: 14.75"w x 9.875"h Output @ 100% Giant Strategy Learn more at XtandiHCP.com XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, ... View Full Source

Enzalutamide In Metastatic Prostate Cancer Before Chemotherapy
DNA.15 In a phase 1–2 trial, enzalutamide was found to have encouraging antitumor activity in men with castration-resistant prostate cancer, with ¶ PSA progression was based on criteria of the Prostate Cancer Clinical Trials Working Group 2. ... Retrieve Content

Dr. Tomasz Beer - Us Too
In Volume 16 Number 3, Prostate Forum explores XTANDI® (enzalutamide) with Dr. Tomasz Beer, the principle investigator in a very important clinical trial about the new drug. ... Fetch Doc

Journal Of Clinical Oncology Publishes Results From The STRIVE Trial Of Enzalutamide Compared To Bicalutamide In ...
Medivation, Inc. and Astellas Pharma US, LLC, a United States subsidiary of Tokyo-based Astellas Pharma Inc. , today announced that results from the STRIVE trial of enzalutamide compared to bicalutamide ... Read News

Oral, Once-daily XTANDI Is Administered As 160 Mg, In Four 40 ...
Adverse Reactions The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal ... View Full Source

Scientific Program - Aua2016.org
No clinical trial experience re-administering XTANDI to patients who experienced a seizure, Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical ... Visit Document

Convenient, Oral, Once-daily Dosing - XTANDI (enzalutamide)
Convenient, oral, once-daily dosing XTANDI is administered as four 40 mg capsules (160 mg) once daily There is no clinical trial experience re-administering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with ... Fetch Document

Survival Rate - Wikipedia, The Free Encyclopedia
Survival rate is a part of survival analysis, the median has the advantage that it can be calculated once 50% of subjects have reached the clinical endpoint of the trial, whereas calculation of an arithmetical mean can only be done after all subjects have reached the endpoint. [2] ... Read Article

3 DOSAGE FORMS AND STRENGTHS FULL PRESCRIBING INFORMATION ...
Prescribing information for XTANDI. XTANDI (enzalutamide) capsules for oral use Initial U.S. Approval: 2012 RECENT MAJOR CHANGES There is no clinical trial experience re-administering XTANDI to patients who experienced seizure. ... View Document