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Proof-of-concept (PoC) Study of APD515

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01331746
First received: April 7, 2011
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Xerostomia in Advanced Cancer Patients
Drug: APD515
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Acacia Pharma Ltd:

Primary Outcome Measures:
  • Xerostomia score [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Change in score on 100 mm visual analogue scale


Enrollment: 32
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APD515
Active APD515 treatment 20 mg qds for 7 days
Drug: APD515
20 mg oromucosal-oral administration qds for 7 days
Placebo Comparator: Placebo Drug: Placebo
qds for 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01331746

Locations
Denmark
University of Copenhagen
Copenhagen, Denmark
Hillerød Hospital
Hillerød, Denmark
Århus University Hospital
Århus, Denmark
United Kingdom
Sue Ryder Leckhampton Court Hospice
Cheltenham, United Kingdom
Coventry and Warwickshire Partnership Trust
Coventry, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
John Eastwood Hospice
Mansfield, United Kingdom
Priscilla Bacon Lodge
Norwich, United Kingdom
City Hospital Hayward House Specialist Palliative Care Unit
Nottingham, United Kingdom
Scarborough General Hospital
Scarborough, United Kingdom
Severn Hospice
Shrewsbury, United Kingdom
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
Principal Investigator: Andrew Davies, MD Royal Surrey County Hospital
  More Information

No publications provided

Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT01331746     History of Changes
Other Study ID Numbers: DX10008
Study First Received: April 7, 2011
Last Updated: May 15, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Xerostomia
Mouth Diseases
Salivary Gland Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 24, 2014