NCT00163280

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

February 12, 2008

Status Verified

February 1, 2008

Enrollment Period

1.4 years

First QC Date

September 9, 2005

Last Update Submit

February 11, 2008

Conditions

Mucositis

Keywords

MucositisPeripheral blood stem cell transplant

Outcome Measures

Primary Outcomes (2)

  • Safety: Adverse events

    28 days post-treatment

  • Efficacy: Oral mucositis scale

    28 days post-treatment

Secondary Outcomes (2)

  • Safety: Laboratory monitoring, vital signs, ECG

    28 days post-treatment

  • Pharmacokinetics of ATL-104

Study Arms (4)

1

EXPERIMENTAL

ATL-104 50mg

Drug: ATL-104

2

EXPERIMENTAL

ATL-104 100mg

Drug: ATL-104

3

EXPERIMENTAL

ATL-104 150mg

Drug: ATL-104

4

PLACEBO COMPARATOR

Placebo

Drug: ATL-104

Interventions

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.

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Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with haematological malignancies undergoing chemotherapy in association with PBSCT

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Birmingham, United Kingdom

Location

Research Site

Cambridge, United Kingdom

Location

Research Site

Cardiff, United Kingdom

Location

Research Site

Leeds, United Kingdom

Location

Research Site

Leicester, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Research Site

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Robert Marcus

    Addenbrooke's Hospital, Cambridge, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

February 12, 2008

Record last verified: 2008-02

Locations

GB(8)