Cancer Treatment: Emerging Therapies and Clinical Trails Flashcards
(9 cards)
1
Q
cancer burden
A
- second leading cause of death
- likely to overtake CVD within next 10-20 years
- most advanced cancers are incurable
2
Q
process of drug approval
A
- identification of molecular target
- lead compounds identification
- lead optimisation
- preclinical testing
- phase I clinical trail
- phase II clinical trail
- phase III clinical trail
- new drug approval
- 5-10 YEAR PROCESS
3
Q
what is currently being researched
A
- advances in cancer biology
- advances in pharmaceutical drug design
- advances in clinical trail design
4
Q
Phase I trails
A
- primary objective:
- determine optimal dose and schedule of an investigational agent
- recommended phase II dose
- maximum tolerated dose
- secondary objective:
- pharmacokinetic analyses
- pharmacodynamic analyses
- pharmacogenetic analyses
- anti-tumour responses
5
Q
phase II trails
A
- novel agents tested in 1-4 phase I trails in distinct schedules
- 5-10 tumour types
- exploration of clinical and biological activity in a predefined subset of patients
- providing compelling evidence to support a large phase III trail
6
Q
phase III trails
A
- large scale
- compare new drug/regime with standard therapy/best supportive care
- superiority trail (improves survival?)
- non-inferiority trail (same efficacy BUT less toxic)
7
Q
post phase III trails?
A
- regulatory approval
- phase IV trails
8
Q
types of new cancer drugs
A
- new chemotherapy agents
- targeted agents:
- tyrosine kinase inhibitors, ie. geftinib
- ALK inhibitors, ie. crizotinib
- Ros inhibitors
- monoclonal antibodies, ie. herceptin, cituximab, immuno-conjugates
- immune-checkpoint inhibitors, ie. anti-pd1
- DNA repair inhibition
9
Q
HER-2
A
- breast and gastric cancers
- Herceptin: adjuvant and advanced disease in breast cancer AND advanced disease in gastric cancer
