A Phase 3 interventional study of Nabiximols in Pain and Advanced Cancer, sponsored by Jazz Pharmaceuticals. Completed at 128 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Jazz Pharmaceuticals · Phase 3, Interventional, and Treatment
This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.
This was a 6-month, multicenter, non-comparative, OLE study to evaluate the safety of long-term nabiximols use as an adjunctive measure in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding double-blind phase 3 study and de novo participants. Consenting eligible participants entered the extension study (Day 1) on the same day as the "end of treatment" visit of a parent study or within 7 days of the "end of treatment" visit or on the day of the "safety follow-up visit" of the parent study. The "safety follow-up" visit of a parent study was performed on the same day as Day 1, if the participant did not enter the OLE study on the same day as the "end of treatment" visit of a parent study. De novo participants attended a screening visit 3 to 14 days prior to enrollment (Day 1). All participants commenced dosing on Day 1. Further study visits took place after 2 weeks (Day 15), and every 4 weeks thereafter until the end of treatment period on Day 183 or earlier if the participant withdrew from the study.
Treatment was started as a single spray in the evening on the first day (Day 1). Participants then gradually titrated by 1 additional spray per day to an individualized dose, balancing efficacy and tolerability. Participants had to complete titration within 14 days of their first dose of study drug and then continue at the same dose for the remainder of the study.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's enrollment of 660 is above the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
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Exclusion Criteria:
Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray, in the morning and evening, up to a maximum of 10 sprays per day for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams \[mg\]/milliliter \[mL\]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
Drug: Nabiximols
Also known as: Sativex®
Percent Of Participants With Treatment-emergent Adverse Events
Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.
Time frame: Baseline, Day 183
Change From Baseline In Mean NRS Average Pain During The Last Period
Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score. A negative value indicates an improvement in average pain score from Baseline.
Time frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment
Change From Baseline In Mean Sleep Disruption NRS During The Last Period
Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "did not disrupt sleep" and a score of 10 indicated "completely disrupted (unable to sleep at all)." Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score. A negative value indicates an improvement in sleep disruption score from Baseline.
Time frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers "extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied". Last visit refers to the last visit that a participant completed the assessment.
Time frame: Last Visit (up to Day 183)
Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)
Participants indicated level of constipation on an 11-point NRS, where a score of 0 was "no constipation", and 10 was "constipation as bad as you can imagine." Last visit refers to the last visit that a participant completed the assessment. Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score. A negative value indicates improvement in condition from Baseline.
Time frame: Baseline, Last Visit (up to Day 183)
Participants enrolled in this study included those who had taken part in studies NCT01262651 (GWCA0958), NCT01361607 (GWCA0962), and NCT01424566 (GWCA1103) and who chose to continue treatment by enrolling in this study, as well as new (de novo) participants who met all inclusion criteria and did not meet any of the exclusion criteria.
| Milestone | Nabiximols |
|---|---|
| Started | 660 |
| Received at least 1 dose of study drug | 660 |
| Safety population | 660 |
| Efficacy dataset | 659 |
| Completed | 256 |
| Not completed | 404 |
| Withdrew: Adverse event | 237 |
| Withdrew: Withdrawal by subject | 129 |
| Withdrew: Withdrawal by investigator | 33 |
| Withdrew: Met withdrawal criteria | 3 |
| Withdrew: Lost to follow-up | 2 |
Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.
| percent of participants | Nabiximols |
|---|---|
| Percent Of Participants With Treatment-emergent Adverse Events | 82.9 |
Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score. A negative value indicates an improvement in average pain score from Baseline.
| units on a scale | Nabiximols |
|---|---|
| Change From Baseline In Mean NRS Average Pain During The Last Period | 0.0 ± 1.8 |
Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "did not disrupt sleep" and a score of 10 indicated "completely disrupted (unable to sleep at all)." Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score. A negative value indicates an improvement in sleep disruption score from Baseline.
| units on a scale | Nabiximols |
|---|---|
| Change From Baseline In Mean Sleep Disruption NRS During The Last Period | 0.1 ± 1.9 |
The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers "extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied". Last visit refers to the last visit that a participant completed the assessment.
| Participants | Nabiximols |
|---|---|
| Extremely Satisfied | 56 |
| Very Satisfied | 230 |
| Slightly Satisfied | 185 |
| Neutral | 82 |
| Slightly Dissatisfied | 33 |
| Very Dissatisfied | 22 |
| Extremely Dissatisfied | 10 |
Participants indicated level of constipation on an 11-point NRS, where a score of 0 was "no constipation", and 10 was "constipation as bad as you can imagine." Last visit refers to the last visit that a participant completed the assessment. Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score. A negative value indicates improvement in condition from Baseline.
| units on a scale | Nabiximols |
|---|---|
| Change From Baseline In NRS Constipation At Last Visit (Up To Day 183) | -0.1 ± 2.5 |
Collected over Up to Day 197 post-enrollment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nabiximols | — | 301/660 (45.6%) | 291/660 (44.1%) |
| Event | Nabiximols |
|---|---|
| Neoplasm ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 209/660 |
| AnaemiaBlood and lymphatic system disorders | 8/660 |
| VomitingGastrointestinal disorders | 7/660 |
| NauseaGastrointestinal disorders | 6/660 |
| PainGeneral disorders | 6/660 |
| PneumoniaInfections and infestations | 6/660 |
| FallInjury, poisoning and procedural complications | 5/660 |
| Urinary RetentionRenal and urinary disorders | 5/660 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/660 |
| Abdominal PainGastrointestinal disorders | 4/660 |
| Event | Nabiximols |
|---|---|
| NauseaGastrointestinal disorders | 86/660 |
| VomitingGastrointestinal disorders | 59/660 |
| DizzinessNervous system disorders | 51/660 |
| AstheniaGeneral disorders | 50/660 |
| Decreased AppetiteMetabolism and nutrition disorders | 49/660 |
| ConstipationGastrointestinal disorders | 44/660 |
| DiarrhoeaGastrointestinal disorders | 41/660 |
| Neoplasm ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 41/660 |
| AnaemiaBlood and lymphatic system disorders | 39/660 |
| SomnolenceNervous system disorders | 38/660 |
Safety Population: All participants who received at least 1 dose of nabiximols.
| Age, Continuous(years) | Nabiximols |
|---|---|
| Mean | 60.2 ± 11.1 |
| Sex: Female, Male(Participants) | Nabiximols |
|---|---|
| Female | 313 |
| Male | 347 |
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Jazz Pharmaceuticals