Xerostomia in Advanced Cancer PatientsPhase 2NCT01331746
Proof-of-concept (PoC) Study of APD515
A Phase 2 study testing APD515 in people with Xerostomia in Advanced Cancer Patients, run by Acacia Pharma Ltd at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia in Advanced Cancer Patients
- What is being tested?
- APD515
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United Kingdom8 sites
Sue Ryder Leckhampton Court Hospice
Cheltenham
Coventry and Warwickshire Partnership Trust
Coventry
Royal Surrey County Hospital
Guildford
John Eastwood Hospice
Mansfield
Priscilla Bacon Lodge
Norwich
City Hospital Hayward House Specialist Palliative Care Unit
Nottingham
Scarborough General Hospital
Scarborough
Severn Hospice
Shrewsbury
Denmark3 sites
Århus University Hospital
Aarhus
University of Copenhagen
Copenhagen
Hillerød Hospital
Hillerød
About this study
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
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.
- Conditions
- Xerostomia in Advanced Cancer Patients
- Being tested
- APD515, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD515Drug
20 mg oromucosal-oral administration qds for 7 days
PlaceboDrug
qds for 7 days
| Study group | Role | What they receive |
|---|---|---|
| APD515 | Experimental | Active APD515 treatment 20 mg qds for 7 days Receives: Drug: APD515 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia score
Change in score on 100 mm visual analogue scale
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia in Advanced Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acacia Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Davies, MD, Principal investigator, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331746
- Sponsor's protocol ID
- DX10008
- Status last verified
- May 2013
- First submitted
- 7 Apr 2011
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01331746
- Acronym / sponsor ID
- DX10008
- Conditions
- Xerostomia in Advanced Cancer Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Acacia Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APD515 | Experimental | Drug: APD515Active APD515 treatment 20 mg qds for 7 days |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APD51520 mg oromucosal-oral administration qds for 7 days | Drug | APD515 |
| Placeboqds for 7 days | Drug | Placebo |
Primary outcome
Xerostomia score
Time frame: 1 week
Change in score on 100 mm visual analogue scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Davies, MD principal investigator
Royal Surrey County Hospital NHS Foundation Trust
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APD515 in people with Xerostomia in Advanced Cancer Patients, run by Acacia Pharma Ltd at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia score (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.