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

Acacia Pharma Ltd11 sites in 2 countries32 target enrollmentSeptember 2011

ConditionsXerostomia in Advanced Cancer Patients

InterventionsAPD515 Placebo

DrugsAPD515 Placebo

Overview

Phase: Phase 2
Intervention: APD515
Conditions: Xerostomia in Advanced Cancer Patients
Sponsor: Acacia Pharma Ltd
Enrollment: 32
Locations: 11
Primary Endpoint: Xerostomia score
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Acacia Pharma Ltd

Responsible Party

Sponsor

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 ≤
•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.

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 APD
•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.