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
- 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
- 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.
- 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
- 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
- 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.