Introduction

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Overview

Cancers endemic in the Asia-Pacific region are underrepresented in the phase I trials performed in the West. Even cancers common worldwide, population-related cancer biology and pharmacogenomics sometimes contribute to differences in patient outcomes between clinical trials performed in the Asia-Pacific region and the United States. To perform phase I trials in the Asia-Pacific area is critical to oncology drug development. We proposed to form the Taiwan Clinical Trial Consortium - Oncology Phase I Trials (TACC-P1). The participating investigators will be oncology phase I trial specialists from the National Taiwan University Hospital, the National Cheng Kong University Hospital, and the National Health Research Institute. Besides, conventional approaches to determine dose based on maximum tolerability and efficacy based on objective tumor response may not be suitable for targeted agents, since many of them have a wide therapeutic index and inhibit tumor growth without demonstrable cytotoxicity. The core facility of TACC-P1 will provide participants the molecular profiling service of 50 samples per year to cover the patients entering oncology phase I clinical trials. Molecular-defined cancer patients are the best and probably the only subjects for future oncology phase I trials.

Mission

  1. To provide the means and opportunity to test promising new compounds in Taiwanese patients with advanced solid tumors refractory to standard therapies
  2. To provide high quality and reliable data through ICH-GCP compliant clinical trials for rapid registration and licensing of new compounds in Taiwan. 
  3. To perform biomarker studies (comprehensive genomic profiling of patients’ tumors).
  4. To perform functional imaging.
  5. To perform pharmacokinetic and pharmacodynamic studies.
  6. To determine the correlation between relevant clinical outcomes and biomarkers or functional imaging endpoints.