Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis

Randomised Double-Blind Placebo-Controlled Study of Orally Administered ATL-104 to Assess Safety, Tolerance and Effect on Oral Mucositis in Patients Following Treatment With Chemotherapy and Peripheral Blood Stem Cell Transplant (PBSCT)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00163280

Enrollment

Registered

2005-09-14

Start date

2004-07-31

Completion date

2005-12-31

Last updated

2008-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis

Keywords

Mucositis, Peripheral blood stem cell transplant

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.

Interventions

DRUGATL-104

Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients with haematological malignancies undergoing chemotherapy in association with PBSCT

Exclusion criteria

* Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT * Visible oral disease * Significantly reduced platelet and neutrophil count

Design outcomes

Primary

Measure	Time frame
Safety: Adverse events	28 days post-treatment
Efficacy: Oral mucositis scale	28 days post-treatment

Secondary

Measure	Time frame
Safety: Laboratory monitoring, vital signs, ECG	28 days post-treatment
Pharmacokinetics of ATL-104	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026