Navigation Links
Lilly Suspends Phase III Trial in Metastatic Melanoma
Date:12/13/2010

INDIANAPOLIS, Dec. 13, 2010 /PRNewswire/ -- Eli Lilly and Company announced today that it has suspended its global Phase III study evaluating tasisulam, an investigational, small-molecule anti-cancer compound, as a second-line treatment for those with unresectable or metastatic melanoma.

Lilly, in consultation with an independent data monitoring committee, recommended a "full clinical hold," because of safety concerns.  A full clinical hold ensures that no new or existing patients in the trial receive additional doses of the compound, allowing researchers the time to fully analyze existing data.

Lilly notified regulatory agencies and contacted all trial investigators to provide details on how to manage individuals enrolled in the trial.

"We are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial," said Richard Gaynor, M.D., vice president, oncology product development and medical affairs for Lilly.

Lilly continues to develop tasisulam as part of an extensive clinical development program across a wide range of tumors, including soft tissue sarcoma, breast, ovarian and renal cancers, as well as non-small cell lung cancer and acute leukemia. At this time, these trials continue without modification because the dosing of tasisulam is different. Lilly is closely evaluating patient safety within these trials on an ongoing basis.

"We remain committed to Lilly Oncology's active fight against cancer, especially for patients facing cancers where the need for new treatments is especially great," added Gaynor.

The Phase III trial sought to compare the efficacy, safety and tolerability of tasisulam versus paclitaxel, as a second-line treatment for those with metastatic melanoma.  The study enrolled more than 300 patients in 18 countries.  The primary endpoint of this study is overall survival.

Tasi
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
3. Lilly and Glenmark Pharmaceuticals Announce License Agreement
4. Lilly Receives NCQA Design Certification for Depression Care Management Program
5. JDRF and Lilly Partner to Fund Research to Identify Beta Cell Biomarkers
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
8. Lilly and Transition Therapeutics Announce Licensing and Collaboration Agreement
9. Lilly Launches Its First Phase III Trial for Treatment of Alzheimers Disease
10. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
11. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... --  Memorial Hermann Health System and The University ... new partnership to provide a new level of specialized breast ... the greater Houston area. ... provider of professional breast radiology services for five of Memorial ... The Woodlands , Northeast, Southwest and ...
(Date:8/21/2014)... 2014  Publicis Groupe customer engagement agency ... and Healthcare Industry Group Leader, has been featured in ... most inspiring people in the life-sciences industry. Those chosen ... development, marketing, technology, creativity, strategy and medicine. ... partner in its leading Rosetta Consulting practice. In 2012, ...
(Date:8/21/2014)... HAMBURG, Germany , Aug. 21, 2014 /PRNewswire/ ... collaborating with Deutsches Elektronen-Synchrotron ( DESY ), a leading ... to speed up management and storage of massive volumes ... Analytics architecture based on IBM software defined technology ... data at peak performance and help scientists worldwide gain ...
Breaking Medicine Technology:Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 2Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 3Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 4Shannon Hartley Shines in PharmaVOICE 100 2DESY and IBM Develop Big Data Architecture for Science 2DESY and IBM Develop Big Data Architecture for Science 3
... FOREST, Ill., Aug. 17, 2011 Hospira, Inc. (NYSE: ... and medication delivery company, today announced that William G. ... directors. Dempsey brings strong executive management and diverse global ... The addition of Dempsey expands Hospira,s board to 11 ...
... Leading dermatologist Dr. Arielle Kauvar announces ... Care , now offers the newest generation of the ... GlideSafe™ Handpieces. The Pelleve System from Ellman International provides ... Dr. Kauvar is known for offering effective, ...
Cached Medicine Technology:Hospira Expands Board of Directors 2New York Dermatologist Offers the Latest in Pelleve Wrinkle Reduction Technology 2
(Date:8/21/2014)... 21, 2014 The City of Garden ... entertainment and programming for its inaugural “Re:Imagine Garden Grove ... 12, 2014, from 11 a.m. to 4 p.m., 2.85-miles ... cars and the downtown will be filled with diverse ... Community Arts Resources (CARS), for all to enjoy. , ...
(Date:8/21/2014)... Aug. 21, 2014 (HealthDay News) -- Among seniors, dimming ... The study involved more than 2,500 people, aged 65 ... study and again two, six and eight years later. ... the person,s risk of death during the study period, the ... effect, researchers led by Sharon Christ of Purdue University in ...
(Date:8/21/2014)... 21, 2014 A new study published ... increase in disability associated with speech problems from 2001-02 ... than 15% increase in disability associated with hearing problems. ... rising numbers of children who are experiencing communication disorders, ... , On a broader level, the new study, ...
(Date:8/21/2014)... Aug. 21, 2014 Researchers in the United Kingdom ... can quickly and accurately diagnose a number of rare ... study published online today in Ophthalmology , ... Using a single test, doctors were able to tailor ... mutations reducing the time and money spent on diagnosis ...
(Date:8/21/2014)... The report "Industrial Flue Gas Treatment Systems & ... Particulate Control, Mercury Control) by Application (Power Generation, ... Global Trends & Forecasts to 2019" defines and ... & services market with analysis and projection of ... The industrial flue gas treatment systems & services ...
Breaking Medicine News(10 mins):Health News:"Re:Imagine Garden Grove - A Downtown Open Streets Event" 2Health News:"Re:Imagine Garden Grove - A Downtown Open Streets Event" 3Health News:"Re:Imagine Garden Grove - A Downtown Open Streets Event" 4Health News:Failing Vision Tied to Shorter Lifespans for Seniors 2Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 2Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 3Health News:New DNA test for diagnosing diseases linked to childhood blindness 2Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 2Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 3Health News:Industrial Flue Gas Treatment Systems Market Estimated to Worth $59, 546.7 Million by 2019 – Report by MarketsandMarkets 4
... have felt elated using the tanning beds and cannot seem ... the elation than just the look good factor of the ... , have researched the background of the ‘feel good’ ... tan could also be igniting euphoric sensations, akin to the ...
... Jerry Mendell a neurologist, co-director of the Muscular ... professor of pediatrics, neurology and pathology at Ohio ... the Neuromuscular Research Program and Gene Therapy Center ... injection of Asklepios Biopharmaceutical Inc (AskBio’s) Biostrophin, which ...
... 570,000 children under the age of 15 die of AIDS ... - states a new global report highlighting concerns about the ... the World Health Organization (WHO) and the Joint United Nations ... HIV ART in low- and middle- income countries more than ...
... Rayburn, a cardiologist from the University of Alabama, Birmingham, told ... the drug showed no significant difference in the rate of ... or placebos. The drug Vioxx is produced and marketed by ... told a jury that the studies, covering a total of ...
... At fairing well in examining the heart and making ... They fair better than medical students, residents, and other ... in accurately identifying abnormal heart sounds. This was revealed ... Archives of Internal Medicine. ,The study was performed ...
... A new study has found that smoking and drinking at ... has exposed the adverse effects of tobacco and alcohol has ... second leading cause of cancer deaths, and doctors generally recommend ... Typically, the disease is diagnosed in people in their late ...
Cached Medicine News:Health News:Wider Addictive Choices – Now, Tanned Addicts 2Health News:Trial Of DMD Gene Therapy Initiated At Ohio 2Health News:AIDS Deaths On The Rise Due To Low Access To Antiretroviral Treatment 2Health News:Could Long Tern Vioxx Users Suffer From Heart Attacks? 2