Solid Tumours Clinical Trial
Official title:
A Phase 1/2a Study of LON002 (Sublingual Artemether Spray) in Subjects With Advanced Solid Tumours.
This clinical trial will assess whether a medicine called artemether, currently used at a
lower dose to treat malaria, could also be useful in treating cancer. For this trial, the
medicine is given in a new way, as a spray under the tongue. This delivery has several
advantages, including better absorption into the body and it may be easier for people to
take. It will be prescribed to consenting patients with advanced solid tumours, every day
for 4 months, either once or twice a day. (For this study 'advanced tumour' will mean there
are no other effective standard therapy options available to the patient).
The dose will be decided in Phase 1 of the study by initially testing 3 different doses of
the medicine in up to 21 different cancer patients, to make sure it is not too toxic or
causes any side effects.
After this, the highest safe dose identified in the first phase will be tested in up to 66
cancer patients in Phase 2 of the study, to see if the medicine is able to reduce the size
of their tumour or slow down its growth.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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