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

This study has been completed.
Sponsor:
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00163280
First received: September 9, 2005
Last updated: February 11, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Mucositis
Drug: ATL-104
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Further study details as provided by Alizyme:

Primary Outcome Measures:
  • Safety: Adverse events [ Time Frame: 28 days post-treatment ] [ Designated as safety issue: Yes ]
  • Efficacy: Oral mucositis scale [ Time Frame: 28 days post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Laboratory monitoring, vital signs, ECG [ Time Frame: 28 days post-treatment ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of ATL-104 [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: July 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163280

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

No publications provided

Responsible Party: Research and Development Director, Alizyme
ClinicalTrials.gov Identifier: NCT00163280     History of Changes
Other Study ID Numbers: ATL-104/034/CL
Study First Received: September 9, 2005
Last Updated: February 11, 2008
Health Authority: United Kingdom: Department of Health

Keywords provided by Alizyme:
Mucositis
Peripheral blood stem cell transplant

Additional relevant MeSH terms:
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 30, 2014