Clinical Trials in STS Shreyaskumar Patel, M.D.

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Presentation transcript:

Clinical Trials in STS Shreyaskumar Patel, M.D. RR Herring Distinguished Professor of Medicine Center Medical Director, Sarcoma Center Deputy Chairman, Dept. of Sarcoma Medical Oncology Clinical Trials in STS Texas Medical Center Houston, Texas

What are Clinical trials? Research investigations (experiments) designed meticulously to find “new agents” or “improve upon the current SOC” (dose, schedule, toxicities, relapse rate/time, survival, QOL…) “Phases” of drug development Preclinical – Drug screens, PDX, animal model Objective: Determine LD10 Clinical – Phase 1-4 (Human) Clinical Trials

Phase 1 trials Typically not cancer specific (exceptions e.g. targeted therapies), ~ 20-40 patients Primary Objective is to determine the appropriate dose and schedule for humans (MTD, OBD) But, also provides some signal of efficacy in specific subsets

Phase 2 trials Typically VERY cancer specific (exceptions e.g. targeted therapies like NTRKi), ~ 30-50 patients in a single-arm trial Primary Objective is to determine the efficacy and safety in humans Endpoints: Response rate, Clinical Benefit Rate, Progression-free survival Toxicities / side-effects

Phase 3 trials Typically randomized, VERY cancer specific, several hundred patients Primary Objective is to compare the efficacy and safety between new Rx and current SOC Endpoints: Survival, Progression-free survival, Response rate, QOL If indeed superior, new drug/regimen gets FDA approval for commercial use

Phase 4 trials Rarely mandated post marketing by FDA to collect more “real world experience” with side-effects/toxicity profile of the newly approved drug/regimen

How do I find out about Clinical trials in sarcomas Seek consultation with a Sarcoma expert and ask him/her to guide you Appropriateness of a trial vs. SOC (E,T,C) Clinicaltrials.gov Foundations, Advocacy and Support Groups Websites of major cancer centers

Clinical Trials in STS Shreyaskumar Patel, M.D. RR Herring Distinguished Professor of Medicine Center Medical Director, Sarcoma Center Deputy Chairman, Dept. of Sarcoma Medical Oncology Clinical Trials in STS Texas Medical Center Houston, Texas