MucositisPhase 2NCT00163280
Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
A Phase 2 study testing ATL-104 in people with Mucositis, run by Alizyme at 8 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mucositis
- What is being tested?
- ATL-104
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Jul 2004to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with haematological malignancies undergoing chemotherapy in association with PBSCT
Who cannot join
- Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
- Visible oral disease
- Significantly reduced platelet and neutrophil count
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Research Site
Birmingham
Research Site
Cambridge
Research Site
Cardiff
Research Site
Leeds
Research Site
Leicester
Research Site
London
Research Site
Oxford
Research Site
Plymouth
About this study
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)
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
Read the 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.
- Conditions
- Mucositis
- Being tested
- ATL-104
- Keywords
- Mucositis, Peripheral blood stem cell transplant
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATL-104Drug
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ATL-104 50mg Receives: Drug: ATL-104 |
| 2 | Experimental | ATL-104 100mg Receives: Drug: ATL-104 |
| 3 | Experimental | ATL-104 150mg Receives: Drug: ATL-104 |
| 4 | Placebo comparator | Placebo Receives: Drug: ATL-104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse events
Measured: 28 days post-treatment
Efficacy: Oral mucositis scale
Measured: 28 days post-treatment
Secondary outcomes (2)
Safety: Laboratory monitoring, vital signs, ECG
Measured: 28 days post-treatment
Pharmacokinetics of ATL-104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alizyme
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Marcus, Principal investigator, Addenbrooke's Hospital, Cambridge, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163280
- Sponsor's protocol ID
- ATL-104/034/CL
- Status last verified
- Feb 2008
- First submitted
- 9 Sep 2005
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00163280
- Acronym / sponsor ID
- ATL-104/034/CL
- Conditions
- Mucositis
- Keywords
- Mucositis, Peripheral blood stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- AlizymeIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ATL-104ATL-104 50mg |
| 2 | Experimental | Drug: ATL-104ATL-104 100mg |
| 3 | Experimental | Drug: ATL-104ATL-104 150mg |
| 4 | Placebo comparator | Drug: ATL-104Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with haematological malignancies undergoing chemotherapy in association with PBSCT
Key exclusion criteria (3 listed)
- Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
- Visible oral disease
- Significantly reduced platelet and neutrophil count
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATL-104Daily 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. | Drug | 1, 2, 3, 4 |
Primary outcome
Safety: Adverse events
Time frame: 28 days post-treatment
Efficacy: Oral mucositis scale
Time frame: 28 days post-treatment
2 secondary outcomes
Safety: Laboratory monitoring, vital signs, ECG
Time frame: 28 days post-treatment
Pharmacokinetics of ATL-104
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Marcus principal investigator
Addenbrooke's Hospital, Cambridge, UK
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATL-104 in people with Mucositis, run by Alizyme at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse events (time frame: 28 days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2008.