Proof-of-concept (PoC) Study of APD515
Primary Purpose
Xerostomia in Advanced Cancer Patients
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
APD515
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia in Advanced Cancer Patients
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 18 years
- Able and willing to give written informed consent.
- Confirmed primary neoplasm at any site (apart from non-melanoma skin cancers), for which first-line cytotoxic therapy has been completed more than one month prior to study entry. Ongoing palliative, hormonal, cytostatic or "targeted" (e.g., monoclonal antibody, tyrosine kinase inhibitor, etc) therapy is permitted, provided that the risk of oral mucositis in the subject is not judged to be significant.
- Subjective complaint of dry mouth, ongoing for at least two weeks prior to study entry.
- Capacity for salivary stimulation, as demonstrated by stimulated whole saliva flow rate > unstimulated whole saliva flow rate.
- Karnofsky performance score ≥ 60% or ECOG performance status ≤ 2.
Adequate renal and hepatic function and hydration status:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 * upper limit normal (ULN);
- Serum urea < 1.5 * ULN and serum urea:creatinine ratio < 100 (where urea and creatinine expressed in the same units);
- Plasma sodium ≤ ULN.
Adequate haematological function:
- Haemoglobin ≥ 9 g/dL;
- White blood count ≥ 1.0 * 10^9/L;
- Platelet count ≥ 50 *x 10^9/L.
- For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards.
Exclusion Criteria:
- Confirmed diagnosis of Sjögren's syndrome.
- Prior radiotherapy for head & neck cancer, or other substantial doses of radiation delivered to the area of the mouth or salivary glands.
- Significant, symptomatic disease of the oral cavity, including oral candidosis or oral mucositis.
- Allergy to active ingredient or any of the excipients of APD515.
- Use of oral or topical (including ocular) pilocarpine or cevimeline in the two weeks prior to enrolment.
- Concomitant use of procainamide, quinidine or ganglionic blocking agents such as mecamylamine, pentolinium and trimethaphan.
- Intestinal or urinary obstruction.
- Myocardial infarction or intestinal anastomosis within the previous 6 months.
- Participation in an investigational drug or device study within 1 month prior to study entry.
- For female subjects only, a positive pregnancy test.
- Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
Sites / Locations
- University of Copenhagen
- Hillerød Hospital
- Århus University Hospital
- Sue Ryder Leckhampton Court Hospice
- Coventry and Warwickshire Partnership Trust
- Royal Surrey County Hospital
- John Eastwood Hospice
- Priscilla Bacon Lodge
- City Hospital Hayward House Specialist Palliative Care Unit
- Scarborough General Hospital
- Severn Hospice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
APD515
Placebo
Arm Description
Active APD515 treatment 20 mg qds for 7 days
Outcomes
Primary Outcome Measures
Xerostomia score
Change in score on 100 mm visual analogue scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01331746
Brief Title
Proof-of-concept (PoC) Study of APD515
Official Title
Randomised, Double-blind, Placebo-controlled Phase II Proof-of-concept Study of APD515 Solution for Oromucosal and Oral Administration for Relief of Xerostomia in Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acacia Pharma Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to look at the effectiveness of a drug called APD515, designed to be applied to the lining inside the mouth, at relieving dryness of the mouth. Study will compare one week of treatment with APD515 to one week of treatment with matching placebo to see which has better effect on patient's mouth dryness, according to their own score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia in Advanced Cancer Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APD515
Arm Type
Experimental
Arm Description
Active APD515 treatment 20 mg qds for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
APD515
Intervention Description
20 mg oromucosal-oral administration qds for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
qds for 7 days
Primary Outcome Measure Information:
Title
Xerostomia score
Description
Change in score on 100 mm visual analogue scale
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 18 years
Able and willing to give written informed consent.
Confirmed primary neoplasm at any site (apart from non-melanoma skin cancers), for which first-line cytotoxic therapy has been completed more than one month prior to study entry. Ongoing palliative, hormonal, cytostatic or "targeted" (e.g., monoclonal antibody, tyrosine kinase inhibitor, etc) therapy is permitted, provided that the risk of oral mucositis in the subject is not judged to be significant.
Subjective complaint of dry mouth, ongoing for at least two weeks prior to study entry.
Capacity for salivary stimulation, as demonstrated by stimulated whole saliva flow rate > unstimulated whole saliva flow rate.
Karnofsky performance score ≥ 60% or ECOG performance status ≤ 2.
Adequate renal and hepatic function and hydration status:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 * upper limit normal (ULN);
Serum urea < 1.5 * ULN and serum urea:creatinine ratio < 100 (where urea and creatinine expressed in the same units);
Plasma sodium ≤ ULN.
Adequate haematological function:
Haemoglobin ≥ 9 g/dL;
White blood count ≥ 1.0 * 10^9/L;
Platelet count ≥ 50 *x 10^9/L.
For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards.
Exclusion Criteria:
Confirmed diagnosis of Sjögren's syndrome.
Prior radiotherapy for head & neck cancer, or other substantial doses of radiation delivered to the area of the mouth or salivary glands.
Significant, symptomatic disease of the oral cavity, including oral candidosis or oral mucositis.
Allergy to active ingredient or any of the excipients of APD515.
Use of oral or topical (including ocular) pilocarpine or cevimeline in the two weeks prior to enrolment.
Concomitant use of procainamide, quinidine or ganglionic blocking agents such as mecamylamine, pentolinium and trimethaphan.
Intestinal or urinary obstruction.
Myocardial infarction or intestinal anastomosis within the previous 6 months.
Participation in an investigational drug or device study within 1 month prior to study entry.
For female subjects only, a positive pregnancy test.
Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Davies, MD
Organizational Affiliation
Royal Surrey County Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
Country
Denmark
Facility Name
Hillerød Hospital
City
Hillerød
Country
Denmark
Facility Name
Århus University Hospital
City
Århus
Country
Denmark
Facility Name
Sue Ryder Leckhampton Court Hospice
City
Cheltenham
Country
United Kingdom
Facility Name
Coventry and Warwickshire Partnership Trust
City
Coventry
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
Country
United Kingdom
Facility Name
John Eastwood Hospice
City
Mansfield
Country
United Kingdom
Facility Name
Priscilla Bacon Lodge
City
Norwich
Country
United Kingdom
Facility Name
City Hospital Hayward House Specialist Palliative Care Unit
City
Nottingham
Country
United Kingdom
Facility Name
Scarborough General Hospital
City
Scarborough
Country
United Kingdom
Facility Name
Severn Hospice
City
Shrewsbury
Country
United Kingdom
12. IPD Sharing Statement
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Proof-of-concept (PoC) Study of APD515
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