Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LON002 | Experimental | (Artemether sublingual spray) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemether | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the Recommended Phase 2 Dose (RP2D) to be used in Phase 2a of the study | 28 days | |
| Number (%) of patients with clinical benefit in Phase 2a |
| 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Dose limiting toxicities | 16 weeks | |
| Time to progression (TTP), progression free survival (PFS) and overall survival (OS). | 16 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| London Pharma Ltd | Contact | 01865 784485 | davidlaskow-pooley@londonpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Debashis Sarker, MD | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Mazhar Ajaz, MD | Royal Surrey County Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Surrey County Hospital | Not yet recruiting | Guildford | Surrey | GU2 7XX | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077549 | Artemether |
| ID | Term |
|---|---|
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Daryl Bendel, MD |
| Xidea Solutions Ltd. |
| Study Director |
| Guy's and St Thomas NHS Foundation Trust | Recruiting | London | SE1 9RT | United Kingdom |
|
| D009930 |
| Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |