Solid Tumours
Conditions
Keywords
Cancer, Malignant Neoplasm, Anti-cancer drug
Brief summary
The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.
Detailed description
This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit. Long term safety and efficacy will be evaluated.
Interventions
DRUGLON002
Extension study to provide continuing access to LON002 medication.
Sponsors
LondonPharma Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent; 2. Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator; 3. Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol; 4. Able to comply with the protocol LON002-003; 5. Women of child bearing potential must have a negative pregnancy test before the start of treatment; 6. Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter; 7. Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter
Exclusion criteria
1. Has not completed a LondonPharma sponsored parent trial of LON002; 2. Unequivocal evidence of disease progression; 3. Unacceptable toxicity experienced in the parent trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability. | Participants will be followed for the duration of their study treatment, an expected average of 6 months |
Countries
United Kingdom
Contacts
Primary ContactDavid Laskow-Pooley
Outcome results
None listed