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Navigable Slide Index

1. Introduction
2. Outline
3. Phase I study: role in clinical drug development
4. Clinical drug development
5. Phase I study
6. Terminology
7. Phase I study design
8. Phase I study objectives
9. Phase I study design: preclinical requirements
10. Preclinical data PD checklist: efficacy
11. Preclinical data PD checklist: target modulation
12. Preclinical data PD checklist: toxicity
13. Preclinical data PK checklist
14. Phase I study conduct
15. Determination of the RPTD
16. Cytotoxic agent
17. Patient population
18. Starting dose
19. Dose escalation
20. Dose escalation methods (1)
21. Dose escalation methods (2)
22. Phase I study design for non-cytotoxic agents
23. Challenges for evaluation of non-cytotoxic agents
24. Non-cytotoxic agents (1)
25. Non-cytotoxic agents (2)
26. Population
27. Non-cytotoxic agents: starting does and escalation
28. Non-cytotoxic agents: RPTD determination
29. Primary endpoint: toxicity
30. Primary endpoint: PK
31. Primary endpoint: target effects
32. Target effects: role in phase I study conduct
33. Approaches to phase I study design
34. Example of phase I study conduct
35. General considerations for RPTD determination
36. Phase I study of non-cytotoxic agent
37. Clinical trial sample analyses
38. Examples of non cytotoxic phase I studies
39. Cetuximab
40. Erlotinib
41. O6-benzylguanine
42. Phase I review
43. Agents/targets
44. Recommended phase II dose and primary basis
45. Laboratory and imaging studies
46. Summary
47. References

Topics Covered

• Phase I study development: role in clinical drug development
• Terminology
• Phase I study objectives
• Preclinical data requirements
• Efficacy
• Target modulation
• Toxicity
• PK checklist
• Phase I study conduct
• Determination of the RPTD
• Cytotoxic agent
• Patient population
• Starting dose
• Dose escalation
• Dose escalation methods
• Phase I study design for non-cytotoxic agents
• Challenges for the evaluation of non-cytotoxic agents
• Two approaches to study phase I study design driven by target effects
• General considerations for RPTD determination
• Clinical trial sample analyses
• Examples: Cetuximab, Erlotinib, O6-Benzylguanine
• Phase I review
• Agents/targets
• Recommended phase II dose and primary basis

Links

Series:

• Cancer Therapy

Categories:

• Cancer
• Clinical Practice
• Pharmaceutical Sciences

Therapeutic Areas:

• Oncology

Talk Citation

Publication History

• Published on January 6, 2009
• Archived on February 25, 2021

Financial Disclosures

• Dr. Wendy Parulekar has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.