Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
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ClinicalTrials.gov Identifier: NCT00163280 |
Recruitment Status :
Completed
First Posted : September 14, 2005
Last Update Posted : February 12, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mucositis | Drug: ATL-104 | Phase 2 |
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 |
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. |
- Safety: Adverse events [ Time Frame: 28 days post-treatment ]
- Efficacy: Oral mucositis scale [ Time Frame: 28 days post-treatment ]
- Safety: Laboratory monitoring, vital signs, ECG [ Time Frame: 28 days post-treatment ]
- Pharmacokinetics of ATL-104

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163280
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 |
Principal Investigator: | Robert Marcus | Addenbrooke's Hospital, Cambridge, UK |
Responsible Party: | Research and Development Director, Alizyme |
ClinicalTrials.gov Identifier: | NCT00163280 |
Other Study ID Numbers: |
ATL-104/034/CL |
First Posted: | September 14, 2005 Key Record Dates |
Last Update Posted: | February 12, 2008 |
Last Verified: | February 2008 |
Mucositis Peripheral blood stem cell transplant |
Mucositis Stomatitis Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Mouth Diseases Stomatognathic Diseases |