Navigation Links
'Phase 0' Trials Aim to Speed Cancer Drug Development
Date:4/17/2009

percent of new oncology drug applications submitted to the U.S. Food and Drug Administration get approved, according to the National Cancer Institute. One reason is the lack of systems to predict early on which drugs would be useful and which would have too many side effects, Doroshow explained. In fact, 70 percent of phase II drugs don't make it to the third phase because of a lack of efficacy.

"We need to have a better handle on whether or not they are going to be useful sooner," he added.

To speed up development, the National Cancer Institute established the NCI Experimental Therapeutics (NExT) program, of which phase 0 trials are an integral part.

The first-ever phase 0 trial involved ABT-888, an oral drug that inhibits an enzyme critical for repairing DNA damage. It's believed that the drug could improve the effectiveness of chemotherapy. Researchers obtained key data within five months of the study's initiation, which helped guide the design of subsequent phase I trials. The findings were published online April 13 in the Journal of Clinical Oncology.

"I think it's going to lay out a very interesting model for other researchers who are also interested in phase 0 studies," said T. Patrick Hill, senior policy fellow at the Edward J. Bloustein School of Planning and Public Policy at Rutgers, and a clinical research ethics consultant at the Cancer Institute of New Jersey, both in New Brunswick.

Experts expect the model to be used for other types of drugs as well.

Phase 0 trials expose people to less toxicity and involve fewer participants -- 10 to 12, on average, versus 20 to 25 in a phase I trial. Trial participants receive only a limited number of doses -- and much lower doses -- over a shorter period of time. However, because small doses of a drug are given for a short period, participants probably will not realize a therapeutic benefit.

So why participate?

"Altruism is an
'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Ovation further advances development pipeline with new phase III epilepsy study
2. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
3. Mannatech Launches Phase One of New Sales and Training Tools
4. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
5. Manic phase of bipolar disorder benefits from breast cancer medication
6. ARIZONA METH PROJECT Unveils Arizonas Anti-Meth Youth Pledge and Kicks Off Phase Two of Public Awareness Campaign
7. Provectus Pharmaceuticals, Inc. releases summary results of phase 1 metastatic melanoma study
8. Alexza to Initiate the First Phase 3 Trial for AZ-004 (Staccato(R) Loxapine) in Late Q1 2008
9. Iomai Patch-Based Vaccine Cut Rate of Travelers Diarrhea by 75 Percent in Phase 2 Field Study
10. MetLife Foundation Begins New Phase of Award-Winning Parenting Skills Campaign in Collaboration with the Partnership for a Drug-Free America(R)
11. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
'Phase 0' Trials Aim to Speed Cancer Drug Development
(Date:10/1/2014)... 01, 2014 Innovations announces the upcoming ... broadcast on Monday, October 20, 2014 at 7:30 a.m. ... will go behind the scenes to learn about Break ... will explore the practical help and information Break the ... the warning signs of abuse, how to navigate the ...
(Date:10/1/2014)... 01, 2014 Anti Aging Clinic (AntiAgingClinic.ca), ... rejuvenating destination of choice, is announcing a discounted cost ... to December. , “We’re doing this because we want ... our top skin clinic in Toronto,” says Dr. Brian ... much at Anti Aging Clinic, including laser facials, genesis ...
(Date:10/1/2014)... at the occasion of the Leishmaniasis East Africa ... and international leishmaniasis experts, results of a pharmacovigilance ... plan, carried out by MSF, DNDi, and ... were presented to key decision makers in order ... with the combination of Sodium Stibogluconate and Paromomycin ...
(Date:10/1/2014)... HILLS, CA (PRWEB) October 01, 2014 ... Reshad will speak to a group of dental specialists ... in the northern Spain city of Oviedo. Dr. Reshad ... prosthodontist and lecturer with clients on two continents, will ... complex and aesthetic full mouth reconstruction. , “These specialists ...
(Date:10/1/2014)... October 01, 2014 Two bicyclists began ... them across the country in an effort to raise ... families. The cyclists, a father-daughter team, plan to ... in Blaine, Washington and finishing in Key West Florida. ... For The Warriors®, a national nonprofit organization that assists ...
Breaking Medicine News(10 mins):Health News:Innovations to Explore Breakthroughs in Health and Wellness in Upcoming Episode Airing Monday, October 20, 2014 via Discovery Channel 2Health News:Anti Aging Clinic, the GTA’s Premier Provider of Anti Aging Treatments, Announces Deal on Units of Botox 2Health News:Results of large-scale roll out of combination treatment for kala-azar in Eastern Africa 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 3Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 4Health News:Father-Daughter Cycling Duo to Ride Cross-Country to Benefit Hope For The Warriors 2
... , , Gates ... and a Bright One , SEATTLE , Jan. ... & Melinda Gates Foundation, today released his second annual letter -- ... innovation impacts priorities of the foundation. , Gates is optimistic that, ...
... or ambidextrous, are more likely to have mental health, ... left-handed children, according to a new study published today ... researchers behind the study, from Imperial College London and ... teachers and health professionals to identify children who are ...
... shows it may have prevented, treated eye infections , ... makeup worn thousands of years ago by Queen Nefertiti ... to enhance beauty alone: New research suggests that the ... disease. , Some ancient Egyptians thought their lead-based ...
... ... billing and practice management services nationwide, announces today its’ addition of three exceptional leaders ... as Client Managers, while Jamie Hays has come aboard as the Client Accounting Manager. ... Columbus, OH ...
... , ... have identified brain networks damaged in Parkinson’s disease have new evidence that these systems ... network appear to respond in a last ditch attempt to rescue the brain. ... Manhasset, NY (Vocus) ...
... , SCOTTSDALE, Ariz. , Jan. 22 ... real estate investment trust, announced the execution of a purchase ... office portfolio located in Atlanta, Georgia for approximately ... to a number of conditions. , The medical office portfolio ...
Cached Medicine News:Health News:Bill Gates Releases Annual Letter 2Health News:Bill Gates Releases Annual Letter 3Health News:Mixed-handed children more likely to have mental health, language and scholastic problems 2Health News:Mixed-handed children more likely to have mental health, language and scholastic problems 3Health News:Explosive Growth Fuels Expansion of ADVOCATE's Management Team 2Health News:Explosive Growth Fuels Expansion of ADVOCATE's Management Team 3Health News:Brain Abnormalities in Parkinson's Patients Develop Before Symptoms Occur, According to Feinstein Scientists 2Health News:Brain Abnormalities in Parkinson's Patients Develop Before Symptoms Occur, According to Feinstein Scientists 3Health News:Healthcare Trust of America, Inc. Executes Agreement to Acquire 80,562 Square Foot Medical Office Portfolio Located in Atlanta, Georgia 2Health News:Healthcare Trust of America, Inc. Executes Agreement to Acquire 80,562 Square Foot Medical Office Portfolio Located in Atlanta, Georgia 3
(Date:9/30/2014)... 30, 2014  Alimera Sciences, Inc. (NASDAQ: ... the research, development and commercialization of prescription ophthalmic pharmaceuticals, ... advance from Hercules Technology Growth Capital, Inc. (NYSE: ... and final advance under the Loan and Security Agreement ... , Alimera Sciences Limited, entered into with Hercules ...
(Date:9/30/2014)... -- A study using a relatively new imaging tool, ... the composition of carotid artery disease and has the ... disease, a leading cause of stroke. ... 2010 and May 2012, was featured in the June ... College of Cardiology (JACC) Cardiovascular Interventions. Interventional cardiologist ...
(Date:9/30/2014)... Valeant Pharmaceuticals International, Inc. (NYSE: ... company,s Bridgewater, New Jersey location ... Drug Administration (FDA) relating to an inspection in June ... Aesthetic injectable, which was divested to Galderma S.A. in ... Valeant,s contract manufacturers (rather than Valeant,s own internal manufacturing) ...
Breaking Medicine Technology:Alimera Sciences Receives $25 Million Advance from Hercules Technology Growth Capital 2New Imaging Tool May Allow Tailoring of Stroke Prevention to Each Patient 2Valeant Pharmaceuticals' Bridgewater Location Receives Warning Letter From FDA 2
... PRINCETON, N.J. , May 3 Covance Inc. (NYSE: ... 35th Annual Health Care Conference on Tuesday, May 4, 2010 at ... presentation at www.covance.com .  In order to register and download any necessary ... , , ...
... DEERFIELD, Ill. , May 3 Today ... " Science WoRx , " a program designed ... The program features a hands-on education and mentoring program, an ... Science WoRx is hosting a competition, "Make ...
Cached Medicine Technology:New Science Education Program Responds to President's Call to Help Young People Excel in Science 2New Science Education Program Responds to President's Call to Help Young People Excel in Science 3New Science Education Program Responds to President's Call to Help Young People Excel in Science 4
... Centuries of German Craftsmanship ... instrumentation in the world. Ocutek ... you! Only holders of the ... and eight-year apprenticeship, are qualified ...
... German Craftsmanship have produced the ... world. Ocutek now makes them ... of the coveted Meisterbrief certificate, ... are qualified to become Ocutek ...
... Central platform with integrated neck. ... platform utilizing an internal spring to ... use. Cutting Block fits into precision ... trephine blades sized 6.25 - 9.0mm. ...
... Central platform with integrated neck. ... platform utilizing an internal spring to ... use. Cutting Block fits into precision ... trephine blades sized 6.25 - 9.0mm. ...
Medicine Products: