About I-SPY Trials

The Problem


The process of developing cancer drugs is prohibitively expensive and prone to failure

Currently, it takes $2.5 billion, 12-15 years, and the involvement of 2,000 to 8,000 patient volunteers to bring one drug to market. Despite this high cost, historically, 60-70% of Phase 3 oncology trials have negative results or fail to complete. Each Phase 3 trial that fails is a lost opportunity to invest in one that is more likely to succeed. We are doing a poor job of identifying the agents most likely to succeed, and a poor job of identifying the patients most likely to respond and investing significant resources for a low yield. Our current system is failing the patients who most need new options.

 

Our Solution


The I-SPY TRIALs are an unprecedented and Streamlined approach to clinical trial design.

I-SPY is a re-engineered approach to clinical trials. Our goal is to get the right drug to the right patient at the time they will benefit most, and to do this faster.  Additionally, we aim to significantly reduce the overall cost, time, and number of patients required to bring new drugs to market.The I-SPY TRIAL Program integrates and links Phases I (I-SPY Phase 1), Phase II (I-SPY 2), and, eventually, Phase III (I-SPY 3) to build a pipeline of novel agents and accelerate the process of identifying the subset of high risk breast cancer patients that will benefit from these new agents, and get the drug to market.





Sponsor

 


I-SPY 2 is a unique public/private partnership and collaboration between QuantumLeap Healthcare Collaborative, Foundation for the National Institutes of Health, the Food and Drug Administration, the National Cancer Institute, 16 leading academic centers (researchers and physicians), the Safeway Foundation, and patient advocates. 

 I-SPY 2 is sponsored by QuantumLeap Healthcare Collaborative, a nonprofit organization with a mission to accelerate transfer of high-impact research in clinical processes and systems technology into widespread adoption so that patients and physicians can benefit from the research as soon as practicable.  

 

 

 





 

How Can You Help?

 

 

The I-SPY 2 TRIAL is looking for individual and corporate supporters to help us advance this very important research. This project will yield benefits to patients by allowing new cancer treatments to be approved much faster and at much lower cost. Additionally, the lower investment threshold for drug approval means that new treatments for smaller patient populations will be able to reach the market.

 

For pharmaceutical companies, the benefits of I-SPY 2 TRIAL is immense. By reducing many years and many hundreds of subjects from the standard clinical trial today, I-SPY 2 can...

read more

 

How Can You Help?

 

 

The I-SPY 2 TRIAL is looking for individual and corporate supporters to help us advance this very important research. This project will yield benefits to patients by allowing new cancer treatments to be approved much faster and at much lower cost. Additionally, the lower investment threshold for drug approval means that new treatments for smaller patient populations will be able to reach the market.

 

For pharmaceutical companies, the benefits of I-SPY 2 TRIAL is immense. By reducing many years and many hundreds of subjects from the standard clinical trial today, I-SPY 2 can save hundreds of millions in drug development costs.

 

If you are an individual supporter, you can donate via the Donate button on this website, or please contact us at: info@ispy2.org. We will be happy to answer any questions you may have about your support for the trial.

 

If you are representing a corporate entity (for-profit or non-profit), we welcome your interest in support for the I-SPY 2 TRIAL. Please contact us at: info@ispy2.org

 

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Timeline

I-SPY TRIAL Milestones

 


 
2002
Launch of I-SPY 1

The I-SPY 1 TRIAL was designed to identify indicators of response to neoadjuvant chemotherapy that predict survival in women with high-risk (Stage II-III) breast cancer.

 
March 2010
LAUNCH OF I-SPY 2  
WATCH VIDEO

 

March 2011
I-SPY 1 : PUBLISHED RESULTS FROM I-SPY 1 TRIAL (READ MORE)

 
january 2012
Accelerated Approval guidance issued by FDA
 
August 2013
I-SPY 3 Protocol approved
 

 

 
December 2013
GRADUATED: NERATANIB (PUMA BIOTECHNOLOGY)
HER2+ HR-HER2+ HR-  
(READ MORE)
 
DECEMBER 2013
GRADUATED: VELIPARIB (ABBVIE)
HER2- HR- (TRIPLE NEGATIVE)
(READ MORE)

 


MAY 2015  
GRADUATED: MK-2206 (MERCK)
HR-, HR-/HER2+, HER2+  
(READ MORE)

DECEMBER 2015  
COMPLETED EVALUATION: AMG 386 (AMGEN)
HR-, HER2+ : RESULTS PROMISING
(READ MORE)

MARCH 2015
I-SPY PHASE 1 NETWORK

STAY IN TOUCH

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