Pain associated with cancer MedDRA version: 21.1 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: BCT-521
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CANNABIDIOL
CAS Number: 13956-29-1
Other descriptive name: CANNABIDIOL
Concentration unit: mg milligram(s)
Concentration
Sponsors
Beckley Canopy Therapeutics Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following criteria are to be checked at the time of enrolment. The patient may be included in the study only if ALL the following criteria are fulfilled: 1. Willing and able to give informed consent 2. Male or female, age 18 years or older 3. Diagnosed with any type of active cancer at any stage 4. Diagnosed with cancer-related pain that is not wholly alleviated with their current opioid treatment and whose average pain NRS score over 24 hours is at least 4 but no greater than 8 during the last 3 days of screening, with no more than a 2-point difference between the highest and lowest scores, with all scores remaining between 4 and 8 5. Maximum daily opioid maintenance dose equal to or less than 120 mg of morphine equivalent, with an overall daily opioid dose equal to or less than 200 mg of morphine equivalent, including the administration of rescue medication for break through pain. It must be confirmed that the use of rescue medication is solely for break through pain 6. Able (in the Investigator’s opinion) and willing to undertake and comply with all study requirements 7. Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 173 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 87
Exclusion criteria
Exclusion criteria: The following criteria should be checked at the time of enrolment. If ANY of the criteria apply, the patient must not be included in the study: 1. Patients who have an Eastern Cooperative Oncology Group (ECOG) score greater than 1 (an ECOG score of 2 is allowed if the patient’s mGPS is 0-1) 2. Known history of controlled substance abuse within the last 3 years 3. Patients with current brain metastases 4. Positive laboratory test for THC and/or CBD 5. Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness 6. Received any epidural analgesia within 1 month prior to Screening or expected during the study 7. Receiving any chemotherapy regimen that, in the Investigator’s opinion, could affect pain positively or adversely, during the study 8. Currently receiving carbamazepine 9. Radiotherapy within 6 weeks of Screening, or planned radiotherapy 10. Unable to give informed consent 11. History of any type of schizophrenia, any other psychotic illness, a serious personality disorder, or other significant psychiatric illness other than anxiety/depression associated with their chronic pain and/or in response to the underlying condition 12. Unwilling to refrain from concomitant use of cannabis or cannabinoids (dried or fresh plant and oil administration by ingestion or other means) throughout the study 13. Patients with an uncontrolled cardiovascular disorder 14. Significant impairment of renal function as evidenced by a creatinine clearance rate of <40 mL/min by Cockcroft-Gault at Screening 15. Significant impairment of hepatic function at Screening as determined by: a. Aspartate aminotransferase (AST) =2.5 × the upper limit of normal (ULN) b. Alanine aminotransferase (ALT) =2.5 × the ULN 16. History of epilepsy 17. Female patients who are pregnant or lactating or of childbearing potential and not willing to use adequate forms of contraception during the study and for 3 months thereafter 18. Male patients who are sexually active and not willing to using adequate forms of contraception during the study and for 3 months thereafter (see Section 6.2.5) 19. Patients who have received an investigational medicinal product as part of a clinical research study within the last 4 weeks prior to Screening 20. Patients who, in the opinion of the Investigator, are not suitable to participate in the study for any other reason not mentioned in the entry criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to: • Evaluate the efficacy of BCT-521 as measured by average pain score, based on an NRS as compared with placebo in patients with cancer pain who are already receiving standard of care treatment with opioids • Evaluate the safety of BCT-521 given twice daily for up to 5 weeks as measured by AEs and laboratory changes over time as compared with placebo;Secondary Objective: • Determine the number of patients receiving BCT-521 achieving a 30% reduction in pain compared with placebo on the average pain NRS • Determine the number of patients receiving BCT-521 achieving a 30% reduction compared with placebo on the Total Brief Pain Inventory (BPI), which includes all the pain and interference items • Determine the mean change from baseline on BPI for worst pain in the last 24 hours for patients receiving BCT-521 compared with placebo • Determine the mean change from baseline on the BPI interference items for the BCT-521 and placebo groups • Determine the mean change from baseline on the Total BPI for the BCT-521 and placebo groups • Determine the percent change from baseline for average pain NRS score for the BCT-521 and placebo groups • Determine the percent change from baseline for Total BPI score for the BCT-521 and placebo groups • Determine the mean change in opioid consumption between the BCT-521 and placebo groups;Primary end point(s): The primary endpoint is the change in average pain NRS score over 24 hours from the start of titration to the End of Treatment (EOT) Visit (5 weeks).;Timepoint(s) of evaluation of this end point: End of Treatment (EOT) Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All secondary clinical and exploratory research endpoints will be evaluated from the start of titration to the EOT (5 weeks). • The number of patients receiving BCT-521 achieving a 30% reduction in pain compared with placebo on the average pain NRS • The number of patients receiving BCT-521 achieving a 30% reduction compared with placebo on the Total BPI, including all pain and interference items • Mean change from baseline on BPI worst pain in the last 24 hours • Mean change from baseline on BPI interference for BCT-521 versus placebo • Mean change from baseline on the Total BPI for BCT-521 versus placebo • The percent change from baseline for average pain NRS score for the BCT-521 and placebo groups • The percent change from baseline for Total BPI score for the BCT-521 and placebo groups • Mean change in opioid consumption (total daily opioid usage) for BCT-521 versus placebo;Timepoint(s) of evaluation of this end point: End of Treatment (EOT) Visit | — |
Countries
Poland
Contacts
Public ContactHead of Clinical Operations
Beckley Canopy Therapeutics Ltd.
Outcome results
None listed