Clinical trial NCT01331746: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Xerostomia in Advanced Cancer Patients
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Xerostomia score
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Hillerød
country: Denmark
facility: Hillerød Hospital
city: Århus
country: Denmark
facility: Århus University Hospital
city: Cheltenham
country: United Kingdom
facility: Sue Ryder Leckhampton Court Hospice
city: Coventry
country: United Kingdom
facility: Coventry and Warwickshire Partnership Trust
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Mansfield
country: United Kingdom
facility: John Eastwood Hospice
city: Norwich
country: United Kingdom
facility: Priscilla Bacon Lodge
city: Nottingham
country: United Kingdom
facility: City Hospital Hayward House Specialist Palliative Care Unit
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
city: Shrewsbury
country: United Kingdom
facility: Severn Hospice
Study officials:
affiliation: Royal Surrey County Hospital NHS Foundation Trust
name: Andrew Davies, MD
role: PRINCIPAL_INVESTIGATOR
References: