Case Study 5

Phase I Trial Maximum Dose Tolerance / Advanced Cancer Patients


Successful Oncology Phase 1 studies require enrolling subjects quickly, monitoring the trial closely for safety and adhering to the precise timing requirements for cohorts’ “starts” and “stops”. TFS was responsible for this first-in-man dose escalation study designed to determine the maximum tolerated dose (MTD).

The clinical trial was conducted in patients with unresectable, relapsed or refractory advanced solid tumors with no curative therapy options. The population was enrolled under one Principal Investigator at one central site and four satellite offices.


  • Subjects presented with the following cancers — colorectal, NSCLC, ovarian, pancreatic, gastric and breast tumors
  • Protocol design required precise timing of the 'starts' and 'stops'
  • Safety data review and assessment required rapid data turnaround for each cohort


  • Completed the enrolment of four cohorts in 16 weeks
  • Conducted 30 on-site interim monitoring visits
  • No turnover was observed among the CRAs — the CRA who initiated the site was the CRA who closed the site
  • TFS' medical monitor attended the first dosing for each cohort and safety assessment visits throughout the trial
  • TFS CRAs monitored each patient’s first dose at each dose level
  • The Safety Monitoring Committee received clean safety data within 48 hours
  • The Trial was completed within budget and one month early – 10 months from contract to CSR


Partnering with TFS, the client proceeded to Phase 2 ahead of schedule.