Title: Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis

Contact:

S. Percy Ivy, MD
Associate Branch Chief
Investigational Drug Branch
Cancer Therapy Evaluation Program
National Cancer Institute
Executive Plaza North, Suite 7131
6130 Executive Blvd.
Rockville, MD 20852
Business: (301)496-1196
Fax: (301)402-0428
E-mail: ivyp@ctep.nci.nih.gov

Objective of Project:

The purpose of this initiative is to expedite assessing in early clinical trials of novel anticancer agents available through the NCI. This RFA will fund programs focused on early clinical anticancer drug development at centers with clinical and scientific experience and patient resources to perform Phase 1 single agent trials, Phase 1 combination trials, limited Phase 2 trials and pilot trials of novel agents for which NCI acquired Investigational New Drug (IND) status. Applicants proposing such programs must be skilled in evaluating investigational agents in early clinical trials and proficient in the characterization of the effects of new agents on their targets in clinical settings. The latter aspect must emphasize integration of appropriate biochemical, pathological, immunological, molecular or imaging methods and in correlating those effects with clinically relevant endpoints.

Description of Project:

The program “Early Clinical Trials with Phase 1 Emphasis” will continue to support a therapeutics development infrastructure through a U01 Cooperative Agreement funding mechanism. The total amount of award funding through re-issuance in 2008 is $8,263,605. The total commitment for five years of funding is $41,318,025. The applicant may request a project period of up to five years, during the award period from January 2008 through December 2013. Support will be provided for scientific leadership, for regulatory and administrative support including protocol development, for data management and analysis, for approximately 14 cooperative agreements and for support of pharmacokinetic and pharmacodynamic studies including imaging. The Phase 1 sites will be expected to submit 8-16 letters of intent, and to initiate/perform 4-10 Phase 1 single agent, Phase 1 combination, limited Phase 2 and pilot studies annually.