Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-02 @ 6:04 PM
Study NCT ID:
NCT02263950
Status:
UNKNOWN
Last Update Posted:
2015-09-07
First Post:
2014-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1/2a Study of LON002 in Subjects With Advanced Solid Tumours
Sponsor:
LondonPharma Ltd.
Organization:
Study Overview
Official Title:
A Phase 1/2a Study of LON002 (Sublingual Artemether Spray) in Subjects With Advanced Solid Tumours.
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LON002-002
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: