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Designing Phase II or III Clinical Trials: Panel Discussion

Designing Phase II or III Clinical Trials: Panel Discussion. Lisa Kachnic MD RTOG Symptom Management Co-chair Radiation Injury Mitigation January 25, 2010. www.rtog.org. 1. sensitivity of the instruments 2. from the MD perspective. 1. burdensome to pt & RA 2. non-compliance & attrition.

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Designing Phase II or III Clinical Trials: Panel Discussion

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  1. Designing Phase II or III Clinical Trials: Panel Discussion Lisa Kachnic MD RTOG Symptom Management Co-chair Radiation Injury Mitigation January 25, 2010 www.rtog.org

  2. 1. sensitivity of the instruments 2. from the MD perspective 1. burdensome to pt & RA 2. non-compliance & attrition 1. need resources 1. need resources

  3. Lessons Learned or Informed Failures • Octreotide Acetate in Prevention of Chemoradiation-Induced Diarrhea in Anorectal Cancer: RTOG Trial 0315

  4. RTOG 0315 • Primary Endpoint: Assuming a 35% placebo acute 3-4 diarrhea incidence rate, detecting a 50% reduction due to LAO with 90% statistical power required 214 patients. • Secondary objectives included assessing the impact of LAO on chemoradiation delivery, medical resource utilization, and patient reported bowel function and QoL.

  5. Lessons Learned? • However, after the first interim analysis, due to lower than expected incidence rates of grade 3 and above diarrhea, the primary endpoint was modified, without loss of statistical power, with DCP approval to include mild diarrhea (grade 2). • Primary Endpoint = negative • Secondary Endpoint = negative • No biologic correlatives • Informed Failure = NO

  6. RIM Trial Design Issues • Choose Relevant & Clear Question • Investigate a documented problem • Work under the umbrella of one of our working groups: • Neurocognition • Protectants for Mucositis (mouth to anus) • Epithelial Injury (skin) • Palliation & QoL (pain, fatigue, sexual) • Late Effects & Survivorship (fibrosis)

  7. Design CCOP Friendly Trial • If pt requires a bone marrow aspirate for antibody production = will not accrue in community setting

  8. RIM Trial Design Issues • Choose PRO primary endpoint • Keep it simple

  9. Drug Pipeline • Clear clinical model (pre-clinical xenografts studies show tissue-specific benefit w documented biologic mechanism/early phase 0 safety data) • Duel agent: mitigates toxicity & enhances outcome • Most promising from today?

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