PHASE II TRIALS OF NEW ANTI-CANCER AGENTS

NIH Guide, Volume 22, Number 14, April 9, 1993



RFA:  CA-93-009



P.T. 34



Keywords:

  Clinical Trial 

  Cancer/Carcinogenesis 

  Chemotherapeutic Agents 

  Pharmacology 



National Cancer Institute



Letter of Intent Receipt Date:  April 1, 1993

Application Receipt Date:  June 10, 1993



The Division of Cancer Treatment of the National Cancer Institute (NCI)

would like to clarify Request for Applications (RFA) CA-93-09,

published in the NIH Guide, Vol. 22, No. 5, February 5, 1993 as

follows:



The section entitled SPECIAL REQUIREMENTS is modified as follows:



2.  The applicant must demonstrate in the application the ability to

meet the following requirements:



a.  documented numbers of eligible patients with a history of adequate

accrual to complete on average two to three Phase II trials annually.



1) information should be provided on the numbers of eligible patients

in each disease category, particularly in, but not limited to, tumors

of special interest such as breast, ovarian, lung and urologic cancers,

that would be available for inclusion in Phase II clinical trials.



2) it is desirable for applications to indicate the relative emphasis

of the proposed projects to each of these disease categories.



The section entitled AWARD CRITERIA is modified as follows:



AWARD CRITERIA



The anticipated date of award is June 10, 1994.  In addition to the

technical merit of the application, NCI will consider how well the

applicant institution met the goals and objectives of the program as

described in the RFA, availability of resources, and balance of study

populations.  While applications may include any malignancy, it should

be noted that those applications that involve anti-cancer agents

particularly relevant to breast cancer and the ability to conduct Phase

II trials in breast cancer will be given a high priority for funding

should additional dedicated funds become available for this purpose.



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