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 - Phase II PoC study of APD515 v1.2

• Conditions: Xerostomia; MedDRA version: 14.0Level: LLTClassification code 10048223Term: XerostomiaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2011-000978-53-DK
• Lead Sponsor: Acacia Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Aged = 18 years
2.Able and willing to give written informed consent.
3.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.
4.Subjective complaint of dry mouth, ongoing for at least two weeks prior to study entry.
5.Capacity for salivary stimulation, as demonstrated by stimulated whole saliva flow rate > unstimulated whole saliva flow rate.
6.Karnofsky performance score = 60% or ECOG performance status = 2.
7.Adequate renal and hepatic function and hydration status:
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN);
•Serum urea < 1.5 x ULN and serum urea:creatinine ratio < 100 (where urea and creatinine expressed in the same units);
•Plasma sodium = ULN.
8.Adequate haematological function:
•Haemoglobin = 9 g/dL;
•White blood count = 1.0 x 10^9/L;
•Platelet count = 50 x 10^9/L.
9.Willing to use an effective form of contraception during the study and for a period of fourteen days afterwards:
•For male subjects adequate contraception may be achieved through abstinence from sexual intercourse or use of a double barrier method of contraception.
•For female subjects adequate contraception may be achieved through abstinence from sexual intercourse, surgical sterilization (of subject or partner), by being post-menopausal (no spontaneous menstrual period for at least one year), or by the use of a double barrier method of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Confirmed diagnosis of Sjögren’s syndrome.
2.Prior radiotherapy for head & neck cancer, or other substantial doses of radiation delivered to the area of the mouth or salivary glands.
3.Significant, symptomatic disease of the oral cavity, including oral candidosis or oral mucositis.
4.Allergy to active ingredient or any of the excipients of APD515.
5.Use of oral or topical (including ocular) pilocarpine or cevimeline in the two weeks prior to enrolment.
6.Concomitant use of procainamide, quinidine or ganglionic blocking agents such as mecamylamine, pentolinium and trimethaphan.
7.Intestinal or urinary obstruction.
8.Myocardial infarction or intestinal anastomosis within the previous 6 months.
9.Participation in an investigational drug or device study within 1 month prior to study entry.
10.For female subjects only, a positive pregnancy test.
11.Female subjects who are lactating.
12.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified