Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
- Registration Number
- NCT00163280
- Lead Sponsor
- Alizyme
- Brief Summary
This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT
- Detailed Description
Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell Transplant (PBSCT) which requires appropriate and effective management. Mucositis is a condition in which there is inflammation and ulceration of the mouth, throat and gut caused by damage to the mucosal barrier induced by chemo- and radiotherapy. Symptoms include pain, nausea, abdominal cramping, and vomiting. This study will investigate whether ATL-104, when administered as a swallowable mouthwash, is safe and well tolerated in patients undergoing PBSCT and to investigate its potential to reduce the level of severity of mucositis associated with PBSCT.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Patients with haematological malignancies undergoing chemotherapy in association with PBSCT
- Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
- Visible oral disease
- Significantly reduced platelet and neutrophil count
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 ATL-104 ATL-104 150mg 1 ATL-104 ATL-104 50mg 4 ATL-104 Placebo 2 ATL-104 ATL-104 100mg
- Primary Outcome Measures
Name Time Method Safety: Adverse events 28 days post-treatment Efficacy: Oral mucositis scale 28 days post-treatment
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of ATL-104 Safety: Laboratory monitoring, vital signs, ECG 28 days post-treatment
Trial Locations
- Locations (1)
Research Site
🇬🇧Plymouth, United Kingdom
Research Site🇬🇧Plymouth, United Kingdom