advanced malignant cancer MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: sativex
Pharmaceutical Form: Pressurised inhalation
CAS Number: 1972-08-3
Current Sponsor code: Marinol®
Elevat®
Other descriptive name: ?9-tetrahydrocannabinol
?9-THC
delta-9-THC4
THC5
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 2.5-
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient has advanced active cancer for which there is no known curative therapy. • The patient is able (in the investigators opinion) and willing to comply with all study requirements. • The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment. • The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the WHO analgesic ladder. • The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 98 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 98
Exclusion criteria
Exclusion criteria: • The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain. • 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 diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug. • The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure). • The patient has experienced myocardial infarction or clinically relevant 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 relevant arrhythmia or myocardial infarction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to determine the effective dose range in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy and on lacking of appetite and malnutrition;Secondary Objective: na;Primary end point(s): The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain). The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain) at time 0,1,2.;Timepoint(s) of evaluation of this end point: The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain). The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain) at time 0,1,2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): non applicabile;Timepoint(s) of evaluation of this end point: na | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica
Istituto Tumori di Napoli
Outcome results
None listed