Phase 1 - ALM201 in advanced ovarian cancer and other solid tumours
Research type
Research Study
Full title
A phase I open-label multi-centre dose-escalation study of subcutaneous ALM201 in patients with advanced ovarian cancer and other solid tumours
IRAS ID
147734
Contact name
Richard Wilson
Contact email
Sponsor organisation
Almac Discovery
Eudract number
2014-001175-31
Research summary
This study will look at the safety of a potential new medication in patients with advanced cancer. This study will be conducted in 2 parts, both looking at the safety of ALM201. Part 1 will recruit patients with advanced cancer of solid tumour types. Part 2 will recruit patients with ovarian cancer as there is growing evidence that anti-angiogenic treatment will be important for ovarian patients.
This is the first time the study drug, ALM201, has been given to patients and will be given as a subcutaneous injection, an injection into the fat layer under the skin. ALM201, is an anti-angiogenic drug, that is, a group of drugs that cut off the blood supply to the tumour and hence block tumour growth. It is thought that ALM201 may act in a different way to other anti-angiogenic drugs and have fewer side effects.
The first patients recruited on this study will receive the lowest dose of ALM201 and followed up for at least 3 weeks on treatment. If this dose level is considered safe, the next few patients will be given a slightly higher dose of ALM201. This will continue until the highest dose but also the safest dose is found.
Part 2 will start once Part 1 is completed and recruit patients only with ovarian cancer. A specific genetic tumour test will be used to ensure that ovarian cancer patients who are more likely to benefit from anti-angiogenic treatment are included in the study.
It is planned that up to 8 hospital sites in the UK will recruit up to 84 patients in total over a period of approximately 18 months. Each patient will attend clinic more regularly than their normal clinical care and be on treatment for a maximum 6 months (Continuation past this point maybe possible depending on drug availability, this would be for a period of 24 weeks maximum, so study treatment for up to 48 weeks in total). Patients will be closely followed up during this study. Before any patients receive the study drug, they will be screened over a period lasting approximately 28 days. During this period, assessments and scans will be done in clinic to check that the patient is suitable for this study.REC name
HSC REC B
REC reference
14/NI/1033
Date of REC Opinion
29 Aug 2014
REC opinion
Further Information Favourable Opinion