Case study

16 Dec 2020

Phase I Trial Maximum Dose Tolerance / Advanced Cancer Patients


Overview

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.


    Challenges

    • 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

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