This is a phase 1 trial. The researchers expect to recruit between 68 to 80 people. This trial has 2 parts.
In the first part of the trial, the first few patients joining have a low dose of LY3143921 hydrate. If they don’t have any serious side effects, the next few patients have a higher dose. And so on, until the doctors find the best dose to give. This is called the dose escalation phase.
In the second part of the trial everybody has the best dose for advanced cancer found in the first part of the trial. This is called the dose expansion phase.
Part 1
You take LY3143921 hydrate as capsules. You have your first dose as a single dose. About a week later you start taking LY3143921 hydrate capsules once a day, or twice a day. Whether you have capsules once or twice a day depends on when you join the trial.
When you have your first dose you stay in hospital for between 1 and 3 nights. During this time the trial team monitor you closely for any side effects. You have tests to check your general health. For example, you have your heart rate and temperature measured. You have your blood pressure checked regularly over the 24 hours following your first dose.
You also have frequent blood tests to see how quickly this drug appears in your body and how quickly your body gets rid of (excretes) the drug. You have a blood test:
- 8 times over the first 24 hours
- once a day on days 2 and 3
You then start treatment with LY3143921 hydrate for 21 days. How many capsules you take each time depends on the dose you have. Each 3 week period is called a cycle of treatment. You have up to 12 cycles as part of this trial. You do not have a break between cycles. So your treatment could take up to 9 months.
You should take LY3143921 hydrate at the same time or times each day. Swallow your tablets whole with water.
On certain days, you may be asked to take the capsules on an empty stomach. So you don’t eat anything 3 hours before and 2 hours after you take the capsules (you can still drink water). Your doctor or nurse will tell you if you need to take your capsules on an empty stomach and when.
Part 2
You have the best dose and frequency of LY3143921 hydrate found in part 1. So this might be once or twice a day, depending on what was decided as a result of part 1.
You take LY3143921 hydrate capsules as described in part 1, except you do not have a single dose for your first treatment.
You stay in hospital for between 1 and 3 nights for your first 1 to 3 doses of LY3143921 hydrate. The trial team monitor you closely and you have frequent blood tests, as described in the first dose for part 1.
You have up to 12 cycles of treatment, so your treatment could take up to 9 months.
Tumour samples
The trial team look at a sample (biopsy 
) of your cancer taken when you were first diagnosed with cancer.
If you are in part 2, you also have biopsies taken of your cancer before treatment and again during your first cycle of treatment. The trial team want to find out how LY3143921 hydrate works and which cancers benefit the most from this drug.
These samples might also be stored and used in future research.
Blood samples
You have extra blood tests as part of this trial. Where possible you have these at the same time as your routine blood tests. The researchers want to find out what happens to LY3143921 hydrate in the body (pharmacokinetics ).
They will also look at the certain genes (pieces of DNA) to find out why this drug might benefit some people, but not others.
