Case study

16 Dec 2020

First in Man Solid Tumor Oncology


Overview

TFS was selected to provide full CRO services including site identification/initiation/training; patient enrollment; project management/monitoring; data management; biostatistics & programming; medical writing, safety, medical monitoring and regulatory consulting. This open study required close follow up on safety and disease.

  • Part One: (Dose Escalation): 3 sites
  • Part Two: (Dose Expansion): 6 sites
  • Study Phase: First in Man, I/IIb
  • Indication: Solid Tumors
  • Sites: 6
  • Services: Full Service


Challenges

Part One:

  • Quick patient enrollment required per cohort. Significant competition with similar oncology treatment trials
  • Close follow-up needed on safety and progressive disease.
  • Complex process to get AIOM/SIAPEC certification for local labs for solid biopsies.
  • Close PK/PD sample management required.
  • Rapid safety data delivery required for the DSMB for each cohort

Part Two:

Slow recruitment was caused by the following factors:

  • The disease indications allowed had been reduced to four cohorts, with more incidence of target receptor expression versus all epithelial cancer in part one
  • Mandatory paired biopsies were required for 60% of the patients. In some of the indications the biopsies were not easy do obtain due the location of the lesions
  • Previous chemotherapy lines were restricted to 3 treatments in part two.

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