• Adjei, Alex (PI)
  • Adjei, Alex (PI)
  • Erlichman, Charles (PI)
  • Kinney, Lea (PI)
  • Kinney, Lea (PI)

Project: Research project

Project Details


We propose to conduct Phase I clinical trials of new anticancer agents or
combinations of anticancer agents for the purposes of characterizing drug
toxicity, determining the maximum tolerated dose, characterizing the
pharmacokinetics and relating the clinical endpoints to the derived
pharmacokinetic parameters and/or relevant biologic endpoints. While the
endpoints are dependent on the therapeutic intent of the specific drug
under study, for cytotoxic agents in general this will be the maximum
tolerated dose. The endpoints for the evaluation of biologic agents alone
or in combination with other agents will be those judged to be induced in
model systems which serve as the rationale for advancement to phase I
clinical trial. The specific aims of these studies are to determine as
efficiently as is compatible with patient safety the appropriate dose of
new anticancer agents selected by the National Cancer Institute for
evaluation of therapeutic activity in subsequent Phase II trials; to
identify pharmacokinetic parameters which may predict toxicity; to develop
limited sampling models which may be used in phase II trials; and to
evaluate biologic endpoints which may be used as surrogate markers of drug
effect. Studies of drug combinations will be designed based on preclinical
data identifying the appropriate schedule and exposure duration of the
agents. Studies of novel modulations of drug effect will be planned to
monitor and evaluate the intended modulation. Each new agent will be
evaluated using a standard modified Fibonacci dose escalating scheme or
using the modified continual reassessment method of dose escalation in a
phase I trial. The studies will be designed to incorporate the appropriate
pharmacokinetic analysis, drug analysis, and pharmacodynamic assessment.
Pharmacokinetic/ Pharmacodynamic modelling of the data and development of
limited sampling models will be performed in those studies in which it is
Effective start/end date6/1/952/28/14


  • National Cancer Institute: $670,900.00
  • National Cancer Institute: $622,307.00
  • National Cancer Institute: $674,349.00


  • Medicine(all)


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