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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Mucositis	Drug: ATL-104	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	63 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	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)
Study Start Date :	July 2004
Actual Primary Completion Date :	December 2005
Actual Study Completion Date :	December 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; ATL-104 50mg	Drug: ATL-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.
Experimental: 2; ATL-104 100mg	Drug: ATL-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.
Experimental: 3; ATL-104 150mg	Drug: ATL-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.
Placebo Comparator: 4; Placebo	Drug: ATL-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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Safety: Adverse events [ Time Frame: 28 days post-treatment ]
2. Efficacy: Oral mucositis scale [ Time Frame: 28 days post-treatment ]

Secondary Outcome Measures :

1. Safety: Laboratory monitoring, vital signs, ECG [ Time Frame: 28 days post-treatment ]
2. Pharmacokinetics of ATL-104

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Cardiff, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Oxford, United Kingdom
Research Site
Plymouth, United Kingdom

Sponsors and Collaborators

Alizyme

Investigators

Principal Investigator:	Robert Marcus	Addenbrooke's Hospital, Cambridge, UK

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Research and Development Director, Alizyme
ClinicalTrials.gov Identifier:	NCT00163280 History of Changes
Other Study ID Numbers:	ATL-104/034/CL
First Posted:	September 14, 2005
Last Update Posted:	February 12, 2008
Last Verified:	February 2008

Keywords provided by Alizyme:

Mucositis; Peripheral blood stem cell transplant

Additional relevant MeSH terms:

Mucositis; Stomatitis; Gastroenteritis; Gastrointestinal Diseases	Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases