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Clinical Trials in Sarcoma: Phases, Objectives, and How to Find Them

Explore the different phases of clinical trials in sarcomas and learn how to find relevant trials through experts, clinical trial websites, cancer centers, and advocacy groups.

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Clinical Trials in Sarcoma: Phases, Objectives, and How to Find Them

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

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