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Trial registered on ANZCTR


Registration number
ACTRN12618001304224p
Ethics application status
Submitted, not yet approved
Date submitted
29/07/2018
Date registered
2/08/2018
Date last updated
4/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Assess the Opioid-Sparing Activity of PAX-1 in Patients with Persistent Cancer Pain.
Scientific title
A Randomised, Double-blind, Parallel-Group, Placebo-Controlled Phase II Study to Assess the Opioid-Sparing Activity of PAX-1 in Patients with Persistent Cancer Pain.
Secondary ID [1] 295677 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent cancer pain 309042 0
Condition category
Condition code
Cancer 307935 307935 0 0
Any cancer
Anaesthesiology 307952 307952 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline period: Placebo: two oral tablets administered twice daily for two weeks
Treatment period: placebo or treatment for six weeks
Arm 1: Pax-1 (sodium meta-arsenite) 7.5 mg/day (one oral tablet in the morning and two oral tablets in the evening) and placebo (daily; one oral tablet in the morning)
Arm 2: Pax-1 (sodium meta-arsenite) 10 mg/day (two oral tablets administered twice daily)
Arm 3: Placebo (two oral tablets administered twice daily)
Optional Open-label extension: Pax-1 10 mg/day (two oral tablets administered twice daily).

All empty containers and any unused study medication will be returned to the pharmacy to await reconciliation by the study monitor.
Intervention code [1] 301997 0
Treatment: Drugs
Comparator / control treatment
Placebo controlled: Tablet (identical formula to PAX-1 excluding active ingredient).
Control group
Placebo

Outcomes
Primary outcome [1] 306911 0
Opioid use as measured by the number of patients with a > 25% reduction in morphine equivalents used. Opioid use will be measured using a Patient Daily Diary.
Timepoint [1] 306911 0
Weeks 4 - 6 of the 6-week double-blind treatment period (Treatment Period 1) when compared to the 2 weeks of the baseline period (Baseline).
Secondary outcome [1] 350070 0
Mean Daily Pain Score when recorded on an 11 (0 – 10) point Numerical Rating Scale (NRS)
Timepoint [1] 350070 0
During the 6-week treatment period (Treatment Period 1) when compared to the 14 day baseline period (Baseline). The Mean Daily Pain Score will be the mean of the seven days preceding the clinic visit day as recorded in the Patient Daily Pain Diary.
Secondary outcome [2] 350071 0
Breakthrough pain frequency (number of days and number of occasions per day). Breakthrough pain medication use will be measured using a Patient Daily Diary.
Timepoint [2] 350071 0
Week 6 of Treatment Period 1 when the patient experiences breakthrough pain), compared to Baseline.
Secondary outcome [3] 350072 0
Short Form Brief Pain Inventory (BPI-SF)
Timepoint [3] 350072 0
Every two weeks during Treatment Period 1 compared with Baseline.
Secondary outcome [4] 350073 0
Patients Global Impression of Change (PGIC)
Timepoint [4] 350073 0
Every two weeks during Treatment Period 1 compared with Baseline.
Secondary outcome [5] 350144 0
Neuropathic Pain Questionnaire (NPQ)
Timepoint [5] 350144 0
Every two weeks during Treatment Period 1 compared with Baseline.
Secondary outcome [6] 350145 0
Opioid Related Symptom Distress Scale (OR-SDS)
Timepoint [6] 350145 0
Every two weeks during Treatment Period 1 compared with Baseline.

Eligibility
Key inclusion criteria
1. Male or female patients 18 years of age and over.
2. Patients with persistent cancer-related pain who are receiving WHO Step 3 cancer pain treatment and require breakthrough rescue on at least 5 days during the Baseline Period.
3. The patients source of pain must be primarily due to underlying cancer.
4. The patients source of pain must be classified as either predominantly nociceptive or neuropathic
5. Patients whose background analgesic medication includes opioids.
6. Patients with a functional status of 0 - 3 as measured using the ECOG Scale of Performance Status.
7. Patients must be competent to understand the nature of the study & capable of giving written informed consent. Be willing to report for the scheduled study visits, complete the study questionnaires, Diary Card and communicate to study personnel about adverse events and concomitant medication use.
8. Patients must have adequate haematological, hepatic and renal functions.
9. Serum electrolyte levels (e.g. calcium, magnesium, potassium, phosphorus) within normal range or deemed not clinically significant by the Investigator.
10. The patient is able to take oral medication
11. Male patients and their female spouse/partner(s) who are of childbearing potential must be using highly effective contraception
12. Female patients of childbearing potential must agree not to become pregnant during the clinical study period and for 6 months after last study drug administration, must have a negative serum pregnancy test at screening and a negative urine pregnancy test within the 7 days prior to randomisation, and must be using highly effective contraception.
13. Female patients must agree not to breastfeed starting at screening and continuing throughout the clinical study period, and for 6 months after last study drug administration.
14. Patients agrees not to participate in another interventional study while participating in the present clinical study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have an addiction to opioids which in the opinion of the investigator would result in the patient being unwilling to reduce their opioid use during the study.
2. The use of prohibited adjuvant pain treatment (including interventional pain procedures) in the 7 days preceding randomisation or a plan to use these medications/procedures during the study, including patients with prolonged use of chronic supratherapeutic doses of paracetamol in excess of 4 g/day and patients using medication containing tetrahydrocannabinol (THC).
3. Patients without a functional digestive system. Subjects with percutaneous gastrostomy (PEG), colectomy, colostomy, and conditions such as irritable bowel syndrome (IBS) will be excluded.
4. New antitumour treatments (chemotherapy and targeted therapies) within the 4 weeks prior to randomisation or planned during the study. However, a stable regimen of hormonal, biological, chemotherapy or targeted therapy is permitted if the dose has remained unchanged for a minimum of 4 weeks prior to randomisation.
5. Patients with documented history of HIV or AIDS, autoimmune disorders (including Crohn’s Disease and Inflammatory Bowel Disease) or history of organ transplantation who require immunosuppressive therapy.
6. Extended field radiotherapy within the 4 weeks prior to randomisation or limited field radiotherapy within the 2 weeks prior to randomisation, or radiotherapy planned during the study for the purpose of relieving pain (haemostatic palliative radiotherapy is permitted).
7. Planned major surgery during the study.
8. Female patients who have been pregnant within the 6 months prior to screening or breastfeeding within the 3 months prior to screening.
9. Patients who require regular medication for a chronic pain syndrome prior to their diagnosis of cancer.
10. Patients with ECG evidence of a QTc greater than 440 milliseconds in men and greater than 460 milliseconds in women, or any other risk factors for torsade de pointes (such as hypokalaemia, hypomagnesemia or hypocalcaemia or family history of long QT syndrome).
11. Patients with uncontrolled cardiac disease (e.g. uncontrolled hypertension (diastolic blood pressure (DBP) >100, or systolic blood pressure (SBP) >180), severe and unstable angina, recent myocardial infarction (within the 12 months prior to screening).
12. Patients with moderate to severe heart failure - New York Heart Association (NYHA) Class III or IV.
13. Patients with known or suspected to have hypersensitivities, allergies to sodium meta-arsenite, related compounds or any of the excipients of the study drug.
14. Treatment with any investigational therapy within the 4 weeks prior to screening.
15. Unresolved toxicity > grade 2, using Common Terminology Criteria for Adverse Events (CTCAE), attributed to any prior therapies (excluding haemoglobin, alopecia, pigmentation, and oxaliplatin-induced neurotoxicity).
16. Patients, who in the opinion of the Investigator, are inappropriate for enrolment into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/09/2018
Actual
Date of last participant enrolment
Anticipated
3/07/2019
Actual
Date of last data collection
Anticipated
3/10/2019
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 300262 0
Commercial sector/Industry
Name [1] 300262 0
Komipharm International Australia
Country [1] 300262 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Komipharm International Australia
Address
11 Monterey Rd Dandenong South Victoria 3175
Country
Australia
Secondary sponsor category [1] 299684 0
None
Name [1] 299684 0
Address [1] 299684 0
Country [1] 299684 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301079 0
BellBerry Limited
Ethics committee address [1] 301079 0
Ethics committee country [1] 301079 0
Australia
Date submitted for ethics approval [1] 301079 0
03/09/2018
Approval date [1] 301079 0
Ethics approval number [1] 301079 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85810 0
Prof Arlene Chan
Address 85810 0
Breast Clinical Trials Unit, Hollywood Private Hospital,
Lower Ground Floor, 101 Monash Ave, Nedlands, Western Australia 6009
Country 85810 0
Australia
Phone 85810 0
+61 (0)8 94814522
Fax 85810 0
Email 85810 0
arlenechan@me.com
Contact person for public queries
Name 85811 0
Gary Mulholland
Address 85811 0
GM Clinical Trials Consultancy Pty Ltd
PO Box 411
Joondalup, Western Australia, 6919
Country 85811 0
Australia
Phone 85811 0
+61 (0)8 9304 2565
Fax 85811 0
Email 85811 0
gmctcwa@tpg.com.au
Contact person for scientific queries
Name 85812 0
Gary Mulholland
Address 85812 0
GM Clinical Trials Consultancy Pty Ltd
PO Box 411
Joondalup, Western Australia, 6919
Country 85812 0
Australia
Phone 85812 0
+61 (0)8 9304 2565
Fax 85812 0
Email 85812 0
gmctcwa@tpg.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.