Registration for a live webinar on 'The role of T cells in COVID from asymptomatic to severe outcomes' is now open.
See webinar detailsWe noted you are experiencing viewing problems
-
Check with your IT department that JWPlatform, JWPlayer and Amazon AWS & CloudFront are not being blocked by your network. The relevant domains are *.jwplatform.com, *.jwpsrv.com, *.jwpcdn.com, jwpltx.com, jwpsrv.a.ssl.fastly.net, *.amazonaws.com and *.cloudfront.net. The relevant ports are 80 and 443.
-
Check the following talk links to see which ones work correctly:
Auto Mode
HTTP Progressive Download Send us your results from the above test links at access@hstalks.com and we will contact you with further advice on troubleshooting your viewing problems. -
No luck yet? More tips for troubleshooting viewing issues
-
Contact HST Support access@hstalks.com
-
Please review our troubleshooting guide for tips and advice on resolving your viewing problems.
-
For additional help, please don't hesitate to contact HST support access@hstalks.com
We hope you have enjoyed this limited-length demo
This is a limited length demo talk; you may
login or
review methods of
obtaining more access.
- Introduction to Cancer Therapy
-
1. Early detection of lung cancer
- Prof. Stephen Lam
-
2. Development of a cancer drug
- Prof. Martin Edelman
- Use of Novel "Targeted" Agents in Combination with Classical Cytotoxic Chemotherapy
-
3. Cytotoxic chemotherapy
- Dr. Michael Sawyer
-
4. Small molecule inhibitors of receptor tyrosine kinases
- Dr. Daniela Krause
- Innovative Strategies of Clinical Drug Development
-
5. Phase II trials
- Dr. Patricia Tang
-
6. Surrogate endpoints of efficacy
- Prof. Maurie Markman
- Biomarkers in Oncology: Rationale Development and Current Use
-
7. Biomarkers in oncology: overview
- Prof. Joe Duffy
- Archived Lectures *These may not cover the latest advances in the field
-
9. Emerging trends in phase II trial design
- Dr. Patricia Tang
-
11. Therapy in cancer 2008: quo vadis?
- Dr. Jeffrey Clark
-
13. Phase III trials
- Prof. Martin Edelman
-
15. Gene profiling in breast cancer
- Dr. Enrique Espinosa
-
18. Understanding cancer trends
- Prof. Michael Thun
-
20. Phase I study design for non-cytotoxic agents
- Dr. Wendy Parulekar
Printable Handouts
Navigable Slide Index
- Introduction
- Outline
- Phase I study: role in clinical drug development
- Clinical drug development
- Phase I study
- Terminology
- Phase I study design
- Phase I study objectives
- Phase I study design: preclinical requirements
- Preclinical data PD checklist: efficacy
- Preclinical data PD checklist: target modulation
- Preclinical data PD checklist: toxicity
- Preclinical data PK checklist
- Phase I study conduct
- Determination of the RPTD
- Cytotoxic agent
- Patient population
- Starting dose
- Dose escalation
- Dose escalation methods (1)
- Dose escalation methods (2)
- Phase I study design for non-cytotoxic agents
- Challenges for evaluation of non-cytotoxic agents
- Non-cytotoxic agents (1)
- Non-cytotoxic agents (2)
- Population
- Non-cytotoxic agents: starting does and escalation
- Non-cytotoxic agents: RPTD determination
- Primary endpoint: toxicity
- Primary endpoint: PK
- Primary endpoint: target effects
- Target effects: role in phase I study conduct
- Approaches to phase I study design
- Example of phase I study conduct
- General considerations for RPTD determination
- Phase I study of non-cytotoxic agent
- Clinical trial sample analyses
- Examples of non cytotoxic phase I studies
- Cetuximab
- Erlotinib
- O6-benzylguanine
- Phase I review
- Agents/targets
- Recommended phase II dose and primary basis
- Laboratory and imaging studies
- Summary
- 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:
Categories:
Therapeutic Areas:
Talk Citation
Parulekar, W. (2009, January 6). Phase I study design for non-cytotoxic agents [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 25, 2024, from https://hstalks.com/bs/1115/.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Wendy Parulekar has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.