04/05/2016
For many years, NCI has partnered with the pharmaceutical industry to develop new cancer therapies. Much of this work has focused on developing therapies that could be used to treat rare cancers, for which there is a great unmet need for effective agents. To enhance our drug development efforts NCI established the Experimental Therapeutics Clinical Trials Network(ETCTN) in 2013. As part of collaborations with pharmaceutical companies, NCI is currently developing more than 60 anticancer agents in ETCTN-supported clinical trials. ETCTN-funded investigators conduct early clinical studies of these agents, while NCI holds the regulatory approval from the Food and Drug Administration (FDA)—known as an IND—to test them. The ETCTN’s goal has been to expand the number of early-phase clinical trials of these promising new agents.
Early Drug Development Opportunity Program: Expanding NCI-supported Early-Phase Clinical Trials
April 5, 2016 by Jeff Moscow, M.D.
For many years, NCI has partnered with the pharmaceutical industry to develop new cancer therapies. Much of this work has focused on developing therapies that could be used to treat rare cancers, for which there is a great unmet need for effective agents.
To enhance our drug development efforts NCI established the Experimental Therapeutics Clinical Trials Network (ETCTN) in 2013. As part of collaborations with pharmaceutical companies, NCI is currently developing more than 60 anticancer agents in ETCTN-supported clinical trials. ETCTN-funded investigators conduct early clinical studies of these agents, while NCI holds the regulatory approval from the Food and Drug Administration (FDA)—known as an IND—to test them. The ETCTN’s goal has been to expand the number of early-phase clinical trials of these promising new agents.
Based on the initial success and growing interest in the program, NCI is now taking steps to create more opportunities for investigators and patients to participate in ETCTN trials.
When it was initially established, ETCTN included investigators from about half of the NCI-Designated Cancer Centers nationwide and from several research institutions in Canada. To be part of the ETCTN, investigators must compete for ETCTN grants, which entails demonstrating that they have sufficient experience conducting clinical trials and be from centers with the necessary facilities and resources to conduct early-phase trials.
This month, NCI is launching the Early Drug Development Opportunity Program (EDDOP), a new pilot program that will open up the ETCTN to many other investigators. The EDDOP provides two ways for investigators at cancer centers that are not designated ETCTN sites to lead or participate in ETCTN trials, making new and novel treatments available to their patients.
Under the first option, investigators at any NCI-Designated Cancer Center will be able to propose a clinical trial to test an investigational drug for which NCI holds an IND. If the institute approves the proposal, the investigators can receive full support to conduct their trial. Under the second option, centers can apply for funding to enroll patients onto certain ETCTN-supported trials.
Drugs selected to be tested in ETCTN-supported trials are brought into the program through the NCI Experimental Therapeutics Program (NExT). The NExT program helps to support the early development of promising investigational drugs—particularly those that may help to address an unmet clinical need, including for rare cancers.
The ECTCN’s chief mission is to advance these promising new agents to the point that they are ready to be tested in later-stage trials, either via NCI’s National Clinical Trials Networkor by the drug company that initially developed the drug. Consequently, ETCTN trials are focused on specific factors that can help to inform the continued development and testing of an agent, such as defining safe dosage levels and delivery schedules, demonstrating that the agent has clinical activity in patients, identifying biomarkers that may predict which patients are most likely to benefit from a drug, and determining whether agents are engaging and/or inhibiting their intended molecular targets.
NCI’s early trials program has a proven track record in helping to develop new therapies that have improved patient care. Examples of FDA-approved drugs that were tested in NCI-supported early-phase clinical trials include oxaliplatin(Eloxitan®) for colorectal cancer, lenalidomide (Revlimid®) for multiple myeloma, and the immunotherapy agent ipilumumab(Yervoy®) for melanoma.
With the ETCTN and EDDOP, NCI hopes to build on and strengthen this record of success.
Investigators from non-ETCTN centers can learn more about the EDDOP and how to take advantage of this important new program on NCI’s website. I and other leaders within NCI’s Cancer Therapy Evaluation Program are confident that EDDOP will allow us to greatly expand this already robust early-phase clinical trial program and thereby speed the development of new therapies for both rare and common tumors.
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