novel and emerging therapies and clinical trials

Question 1

how long does it take to develop a new drug

Answer 1

5-10 years

Question 2

primary objective of phase I trials

Answer 2

1. to determine the optimal dose
2. recommend phase II dose
3. maximum tolerated dose

Question 3

secondary objective of phase I trials

Answer 3

1. pharmacokinetic analyses
2. pharmacodynamic analyses
3. pharmacogenetic analyses
4. anti-tumour responses

Question 4

phase II trial

Answer 4

1. conducted in 5-10 tumour types
2. provides evidence to support investment in large phase III trial

Question 5

phase III trial purpose

Answer 5

compare new drug or regime with standard therapy

Question 6

2 trials within the phase III trial

Answer 6

superiority trial (improve survival) and non-inferiority trial (as efficacious but less toxic)

Question 7

what happens after phase III

Answer 7

• regulatory approval and phase IV

Question 8

4 types of new targetted agents

Answer 8

TKIs, ALK inhibitor, Ros inhibitors, monoclonal antibodies

Question 9

what are the new TKIs

Answer 9

geftinib, erlotinib, afatinib

Question 10

what are the new ALK inhibitors

Answer 10

crizotinib, alectinib, brigatinib, ceritinib

Question 11

what are the new monoclonal antibodies

Answer 11

herceptin, immuno-conjugates, cituximab

Question 12

what do immune-checkpoint inhibitors do

Answer 12

enhances t-cell response towards the tumour

Question 13

example of immune-checkpoint inhibitor

Answer 13

nivolumab

Question 14

what do the new drugs that alter DNA repair do

Answer 14

they inhibit DNA repair leading to synthetic lethality