Metals in Medicine Consortium

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Metals in Medicine Consortium Sydney Cancer
Centre
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• Sydney Cancer Centre
• Clinical Oncology Departments of
• Royal Prince Alfred Hospital
• Medical Oncology
• Radiation Oncology
• Surgical Units (urology, melanoma, breast,
  GI, HN, cardiothoracic, etc)
• Palliative Care
• Haematology
• Concord Hospital
• Dubbo Hospital

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• SCC Clinical Research Links
• Pharmaceutical Industry
• University of Sydney (Med Psychology,
  Chemistry, Pharmacology)
• Australian cooperative groups (disease specific)
• US National Cancer Institute
• US cooperative groups (ph III)
• Cornell University phase II consortium (ph II)
• CTEP organ dysfunction working group (ph I)
• Other international cooperative groups

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• Essential Clinical Resources for Developmental
  Therapeutics Research
• Clinicians
• Patients
• Clinical research staff
• Regulatory infrastructure
• Laboratory interface

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SCC Clinical Capability (Medical Oncology) A/Prof
Michael Boyer Dr Lisa Horvath Dr Philip
Beale Prof John Simes Dr Jane Beith Dr Martin
Stockler A/Prof Stephen Clarke Dr Anne Sullivan
Dr Anne Hamilton Prof Martin Tattersall

• 2000 new patients per year
• 200 patients on clinical trials per year
• 40 active protocols at any point in time
• 12 research staff (nurses / admin) including
• RT / Concord / Dubbo

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• Key SCC Personnel - Metals in Medicine
• Dr Philip Beale
• Director, Med Oncology, CGRH/Dubbo
• GI, gynae, breast, clin pharm
• A/Prof Michael Boyer
• Director, Med Oncology, CSAHS/RPAH
• lung, GU, HN
• A/Prof Stephen Clarke
• Head, Clinical Pharmacology
• GI, lung, clin pharm
• Dr Anne Hamilton
• Head, Clinical Trials
• breast, melanoma, gynae, clin pharm

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• End-points of Phase I studies
• Recommended phase II dose and schedule
• Human toxicology profile
• Pharmacokinetics
• Pharmacodynamics
• Preliminary efficacy data

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• Role of Clinicians in Developmental Therapeutics
  Research
• Protocol Planning (Registration Strategy)
• Patient Selection and Treatment
• Translational Laboratory Research Capability
  (Bench to Bedside)
• Imaging Capability

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• Protocol Planning (Registration strategy)
• selection of schedule / route of administration
• selection of starting dose / dose escalation
  plan
• selection of monitoring according to knowledge
  of toxicities in drugs of same class /
  preclinical data
• development of strategies for managing side
  effects / problems as they occur
• identification of clinical niches for drug
  development
• knowledge of competing molecules

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• Patient Selection and Treatment
• identification of appropriate patients
• informed consent
• drug administration
• monitoring and management of efficacy and
  toxicity
• determination of relationship of clinical events
  to the study drug
• supportive care
• reporting (regulatory)

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• Translational Research CapabilityBench to
  Bedside
• Concord Laboratory
• Cell lines
• In vitro drug activity in sensitive and resistant
  cell lines
• Animal (xenografts / immune competent animals)
• pharmacokinetics (LCMS)
• pharmacodynamics
• toxicology
• anti-tumour activity

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• Translational Research CapabilityBench to
  Bedside
• Human (pretreated cancer / tumour targeted
  population)
• pharmacokinetics (LCMS)
• pharmacodynamics
• PET labelled compounds (tissue distribution /
  real time PK)