/A
- Conditions
- MedDRA version: 21.1Level: PTClassification code 10058019Term: Cancer painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]Pain associated with cancer
- Registration Number
- EUCTR2019-001382-32-PL
- Lead Sponsor
- Beckley Canopy Therapeutics Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method