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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Artemether sublingual spray at 20mg per spray. Dose escalation study design as per protocol; in Phase 1, three dose levels will be given. The Phase 2 dose will be determined from the results of Phase 1. All patients will receive 4 cycles of dosing, 28 days per cycle.
The Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
NOT_YET_RECRUITINGGuy's and St Thomas NHS Foundation Trust
London, United Kingdom
RECRUITINGDetermination of the Recommended Phase 2 Dose (RP2D) to be used in Phase 2a of the study
Time frame: 28 days
Number (%) of patients with clinical benefit in Phase 2a
* Complete or partial response at any time based on imaging * Stable disease at 16 weeks (4 cycles); and/or * Reduction of validated biomarkers
Time frame: 16 weeks
Number of subjects with Dose limiting toxicities
Time frame: 16 weeks
Time to progression (TTP), progression free survival (PFS) and overall survival (OS).
Time frame: 16 weeks
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