Study of Sativex for the Treatment of Cancer Related Pain.

Conditions: Pain in patients with advanced cancer who have inadequate analgesia even with optimized chronic opioid therapy.
MedDRA version: 18.0Level: PTClassification code 10058019Term: Cancer painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-022905-17-HU

Lead Sponsor: GW Pharma Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 540

Inclusion Criteria

Patients meeting the following criteria will be considered suitable to enter into the Eligibility Period for this study at Visit 1:
• Willing and able to give written informed consent.
• The patient is at least 18 years of age or older.
• The patient has advanced cancer.
• The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with his or her current optimized opioid treatment.
• The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations.
• The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids).
• The patient is using no more than one type of break-through opioid analgesia.
• The patient is willing to continue to take their maintenance opioid therapy at the same daily dose, throughout the duration of the study where possible.
• Willing and able to comply with all study requirements.

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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion Criteria

The patient may not enter the study if ANY of the following apply:
• Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain).
• The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study.
• Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug.
• Has poorly controlled epilepsy or recurrent seizures (i.e., one or more seizure during the last year).
• Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
• Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.
• Has significantly impaired renal function as evidenced by a creatinine clearance lower than 40 mL/min at Visit 1.
• Has significantly impaired hepatic function at Visit 1 (ALT >5X upper limit of normal (ULN) or bilirubin (TBL) > 2X ULN). If the ALT or AST >3X ULN and the TBL >2X ULN (or INR >1.5), this patient should not enter the study.
• Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective).
• Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
• Patients who have received a non-approved IMP within 30 days of Visit 1.
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study.
• Travel outside the country of residence planned during the study.
• Patients previously enrolled into Part A of this study or any other Sativex clinical trial for Cancer Pain.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of Sativex, compared with placebo, when used as an adjunctive measure, in relieving uncontrolled persistent chronic pain (not breakthrough pain) in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy.;Secondary Objective: To evaluate the efficacy of Sativex compared with placebo on:<br>• Secondary measures of pain<br>• Sleep disruption<br>• Constipation<br>• Opioid consumption<br>• Change in general function<br>• Treatment failure<br><br>To evaluate the safety and tolerability of Sativex compared with placebo through the following assessments:<br>• Adverse Events (AE)<br>• Survival<br>• Suicidal Tendencies (Columbia Suicide Severity Rating Scale - C-SSRS)<br>• Clinical laboratory tests<br>• Vital signs;Primary end point(s): The primary endpoint is the mean change from baseline to the end of treatment in NRS average pain score.;Timepoint(s) of evaluation of this end point: The last 4 days of IMP treatment in Part B.

Secondary Outcome Measures