None listed
Conditions
Brief summary
The purpose of this study is to assess if the drug PAX-1 can reduce the amount of opiate-based pain medication required to control persistent cancer pain. Who is it for? You may be eligible for this study if you are aged 18 or older, have persistent cancer-related pain and currently use pain management that includes opioids. Study details Participants will be randomised (by chance) into one of three groups. After a 2 week baseline period, each group will take the study medication in addition to their usual pain medication, twice per day for 6 weeks. One group will receive 7.5mg of the study drug, another group 10mg of the study drug, and the final group will receive a placebo. After the 6 weeks, participants can continue on the study with the active drug for 4 weeks if they choose. Throughout the study, participants will complete a daily pain scale and some surveys. It is hoped that information gained in this study will aid in the understanding of persistent cancer pain and help in the development of new approaches to its treatment and the care of future patients who share your condition.
Interventions
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 (
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.
Sponsors
Komipharm International Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed