A study of Sativex for pain Relief and appetite stimulation in Patients with advanced malignancy. Phase II

• Conditions: advanced malignant cancer; MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001739-21-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-13
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): non applicabile;Timepoint(s) of evaluation of this end point: na