E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain in patients with advanced cancer, who experience inadequate
analgesia during optimized chronic opioid therapy. |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety of long-term Sativex therapy when used as an adjunctive (not breakthrough) measure in patients with advanced cancer. |
|
E.2.2 | Secondary objectives of the trial |
To assess the maintenance of effect through long-term usage of Sativex as adjunctive therapy for the relief of uncontrolled persistent chronic cancer related pain. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For inclusion in the study patients must fulfill ALL of the following criteria:
- Patient has completed the parent study within the last seven days.
- Willing and able to give written informed consent.
- Willing and able to comply with all study requirements. |
|
E.4 | Principal exclusion criteria |
Exclusion: The patient may not enter the study if ANY of the following
apply:
•The patient is currently using cannabis or cannabinoid based
medications, other than the parent study IMP, 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).
•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.
•Female patient of child-bearing potential or male patient 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.
•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.
•Has significantly impaired hepatic function at Visit 4 (ALT >5X upper
limit of normal (ULN) or bilirubin (TBL) > 2X ULN). If the ALT or AST
>3xULN and (TBL >2xULN or INR >1.5) this patient should not enter the study. This criterion can only be confirmed once Visit 4 laboratory results are available; patients that entered the study and are later found not to meet this criterion should be withdrawn from the study.
If the parent study Visit 4 laboratory results raise any safety concerns,
the investigator should consider whether it will be appropriate for the
patient to continue to participate in the extension study, or if the patient should be withdrawn. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the incidence of adverse events (AEs). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The following are the study secondary endpoints:
• Columbia Suicide Severity Rating Scale (C-SSRS).
• Vital Signs.
• Hematology and Biochemistry Assessments.
• Weekly average NRS Pain.
• Weekly average Sleep Disruption NRS.
• Constipation NRS.
• Patient Satisfaction Questionnaire (PSQ). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
'End of Treatment Visit' for Visit Assessments. Diary data will be
submitted across time/visits |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Bulgaria |
Czech Republic |
Estonia |
Germany |
Hungary |
Latvia |
Lithuania |
Mexico |
Romania |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |