None listed
Conditions
Brief summary
The purpose of this study is to assess if the drug, PAX-1, can reduce cancer pain when used in addition to usual pain medication. It will also assess the side effects it may cause. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are experiencing moderate or severe, persistent cancer-related pain are in the palliative setting. Study details: Participants in this study will be randomly (by chance) allocated to one of four groups. Participants in three of the groups will receive the study drug, PAX-1, at a dose of either 7.5mg, 10mg, or 12.5mg . Participants in the fourth group will receive a placebo (inactive) tablet. The tablets are taken orally 3 times a day for 28 days. All participants will continue to take their usual pain medication in addition to the study medication. They will not know to which group they have been allocated until after the study. Participants will be asked to record their daily pain intensity on a numerical rating scale. They will also be asked to complete questionnaires on appetite, sleep quality, functional status, and quality of life and will undergo safety and tolerability evaluations involving blood tests, ECGs and monitoring of adverse events. This will enable us to determine the clinical benefit of PAX-1 for cancer patients in the palliative setting.
Interventions
This is a multi-centre double-blind, four arm, parallel, randomised Phase 2 comparison study evaluating the efficacy and safety of PAX 1 verses Placebo in patients with persistent cancer pain.
Patients will be randomly assigned in a 1:1:1:1 ratio (7.5mg, 10mg, 12.5mg or placebo).
In addition to continuing with their usual background pain therapy, patients will take 5 study tablets daily for 28 days. 2 tablets before breakfast, 1 tablet before lunch and 2 tablets before dinner.
Patients wi
This is a multi-centre double-blind, four arm, parallel, randomised Phase 2 comparison study evaluating the efficacy and safety of PAX 1 verses Placebo in patients with persistent cancer pain. Patients will be randomly assigned in a 1:1:1:1 ratio (7.5mg, 10mg, 12.5mg or placebo). In addition to continuing with their usual background pain therapy, patients will take 5 study tablets daily for 28 days. 2 tablets before breakfast, 1 tablet before lunch and 2 tablets before dinner. Patients will be asked to return unused study medication and the empty packaging at each weekly visit to ensure compliance to the study and to conduct patient drug accountability.
Sponsors
Bio And Gene Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Participants with moderate or severe, persistent cancer-related pain who are receiving WHO Step 3 cancer pain treatment. The type of cancer is non specific and the patient should be in palliative care. 2) Pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment 3) Pain intensity must be moderate or severe defined by an average daily pain score of >= 4 achieved over a minimum of 2 days within the 7 days preceding randomisation. 4) Australian-modified Karnofsky Performance Scale Score of >= 50 5) Ability to complete study questionnaires and provide written informed consent 6) Adequate haematological, hepatic and renal functions required 7) Participant is able to take medication orally 8) Women of childbearing potential must have a negative pregnancy test and agree to adequate birth control if conception is possible during the study and up to 6 months after the discontinuation of study medications; and males must agree to adequate birth control during the study and up to 6 months after the discontinuation of study medication.
Exclusion criteria
1) Unstable pain at study Visit 1 (screening visit) and Visit 2 (randomisation visit) 2) Use of prohibited adjuvant pain treatment (including interventional pain procedures) in the 7 days preceding Visit 1 or plan to use these medications/procedures during the study, 3) Participants without a functional digestive system. Participants with percutaneous endoscopic gastrostomy (PEG), colectomy, colostomy, and conditions such as irritable bowel syndrome 4) Antitumour treatments (chemotherapy and targeted therapies) within 2 weeks prior to randomisation or planned to take place during the study. 5) HIV or AIDS, autoimmune disorders (including Crohn's Disease and Inflammatory Bowel Disease) or history of organ transplantation who require immunosuppressive therapy. 6) Has had certain other recent treatment e.g. extended field radiotherapy or limited field radiotherapy within 4 weeks prior to randomisation, or radiotherapy planned to take place during the study for the purpose of relieving pain 7) Planned major surgery during the study 8) Is a Lactating or pregnant female 9) Participants who required regular medications for a chronic pain syndrome prior to their diagnosis of cancer 10) Certain cardiac medical conditions 11) Has received any investigational product in the past 4 weeks prior to starting the study 12) known or suspected hypersensitivities, allergies to sodium meta-arsenite, related compounds or any of the excipients of the study drug (calcium phosphate dibasic anhydrous, silicified microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, and sodium stearyl fumarate) 13) Has any unresolved toxicity to <= CTCAE grade 2 attributed to any prior therapies 14) Taking an anti-platelet and anticoagulant combination or two or more anti-platelet agents. 15) Taking any medication containing arsenic trioxide.
Outcome results
None listed