Advanced CancerPhase 1NCT02432612
A Study to Assess the Pharmacokinetic (PK) Properties of Sativex® in Patients With Advanced Cancer
A Phase 1 study testing Sativex in people with Advanced Cancer, run by GW Pharmaceuticals Ltd.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Sativex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
For inclusion in the trial subjects must fulfil ALL of the following criteria:
- The subject is aged ≥18 years.
- The subject has advanced cancer for which there is no known curative therapy.
- The subject has a clinical diagnosis of cancer related pain, is currently taking Step III opioid therapy and is willing to continue on their current dosing regimen throughout the Inpatient/Treatment Period of the trial.
- The subject is willing and able to give written informed consent.
- The subject is willing and able to comply with all trial requirements.
The subject may not enter the trial if ANY of the following apply:
- The subject is receiving intrathecal opioids via pump mechanism.
- The subject is currently using or has used cannabis or cannabinoid based medications within 30 days of trial entry and is unwilling to abstain for the duration of the trial.
- The subject has 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 60 grams of pure alcohol per day for men, and more than 40 grams of pure alcohol per day for women) and unwilling to abstain from alcohol for 24 hours prior to and during trial visits; current use of an illicit drug or current non prescribed use of any prescription drug.
- The subject has a history of epilepsy as evidenced by one or more seizures in the last 12 months.
- The subject has any known or suspected history or family history of schizophrenia, or other psychotic illness, history of severe personality disorder or other severe significant psychiatric disorder other than depression associated with the underlying condition.
- The subject has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
- The subject has significant cardiac disease, or has a cardiac disorder that in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction, or has a secondary or tertiary atrioventricular block, or evidence of clinically significant cardiac disease on ECG at the Screening Visit.
- The subject has significantly impaired renal function as evidenced by a creatinine clearance (based on measured serum creatinine level) lower than 40 mL/min at Visit 1.
- The subject has significantly impaired hepatic function at Visit 1 (alanine aminotransferase [ALT] >5 upper limit of normal (ULN) or total bilirubin [TBL] > 2 ULN). If the ALT or aspartate aminotransferase [AST] >3 ULN and the TBL >2 ULN [or international normalized ratio [INR] >1.5]) this subject must not enter the trial.
- The subject is a female of childbearing potential, or a male patient whose partner is of childbearing potential, is unwilling to ensure that they and/or their partner use a highly effective method of contraception, including female sterilization (ie, documented bilateral tubal ligation), male sterilization, established use of hormonal methods of contraception (oral, implanted or transdermal), an intrauterine device or intrauterine system, or true abstinence.
- Female subject who is pregnant, lactating or planning pregnancy during the course of the trial and for 3 months thereafter.
- The subject has received a non approved IMP within 30 days or 5 times the half-life of the IMP (whichever is greater) prior to the Screening Visit.
- The subject has 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 trial, or may influence the result of the trial, or the patient's ability to participate in the trial.
- The subject was previously enrolled in the current trial or any other Sativex clinical trial for cancer pain.
- The subject is unwilling to abstain from the consumption of grapefruit products during the week prior to and throughout the Inpatient/Treatment period.
About this study
Official title: An Open-label, Multi-centre, Single-dose Clinical Trial to Assess the Pharmacokinetic (PK) Properties and Tolerability of a Single Oromucosal Dose of 6 Sprays of Sativex® in Patients With Advanced Cancer Currently on Background Step III Opioid Therapy
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy.
Read the detailed description
This is an open-label, multiple-centre, single dose clinical trial to assess the PK of a single oromucosal dose of Sativex in subjects with advanced cancer who are currently on background Step III opioid therapy.
A minimum of 25 subjects ≥18 years with advanced cancer will be needed for the assessment of the primary objective of the trial. The Screening Visit (Visit 1) will be performed within -10 to -2 days prior to dosing. For the Screening Visit, subjects will attend on an outpatient basis.
Subjects will be checked into the clinical research facility on Day -1 and will be confined to the clinical research facility for the Inpatient/Treatment Period (Day -1 to Day 3) (Visit 2). Subjects will be administered a single oromucosal dose of Sativex on Day 1 (time [t]=0). Fourteen PK blood samples will be taken from Day 1 to Day 3 during Visit 2: one predose sample and 13 postdose samples at the following time points after dosing: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours postdose.
Subjects will be discharged from the clinical research facility after the 48-hour PK blood sample has been taken and final safety assessments are completed. Subjects who discontinue from the trial prior to the completion of the PK blood draws will undergo the safety evaluations scheduled for Day 3.
The Safety Follow-up Call (Visit 3) will be made 7 (+2) days after dosing on Day 1. Subjects with any new adverse events (AEs) or clinical laboratory abnormalities will be asked to return for safety follow-up.
The expected duration for trial participation (including Screening Visit, Inpatient/Treatment Period, and Safety Follow-up Call) for each individual subject is a maximum of 19 days.
- Conditions
- Advanced Cancer
- Being tested
- Sativex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called Nabiximols, GW-1000-02, THC/CBD spray
Sativex is supplied as a liquid containing 27 mg/mL Δ9-tetrahydrocannabinol (THC) and 25 mg/mL Cannabidiol (CBD) plus peppermint flavoring. Each 100 µL actuation of the pump-action spray delivers 100 µL 27 mg THC and 25 mg CBD.
| Study group | Role | What they receive |
|---|---|---|
| Sativex | Experimental | Sativex will be administered by trained, clinical trial personnel, via a pump action oromucosal spray. Sativex will be administered as 2 actuations (sprays) under the tongue or inside the cheeks every 4 minutes until 6 sprays have been administered. Following the administration of the first and second set of 2 actuations, patients will be offered 50 mL water to drink; and following the final set of 2 actuations, 100 mL of water will be offered (i.e., a total of 200 mL water will be offered during the Sativex dosing). There must be a period of at least 2 minutes and no more than 3 minutes between Sativex administration and consumption of water. Patients will not be permitted their regular medication until 2 hours post dose of investigational medicinal product (IMP) to minimize any possible drug interactions. Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic endpoints of the analyte delta 9-tetrahydrocannabinol (THC).
- Mean maximum plasma concentration (Cmax) of THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
- Mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC(0-t)) of THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
- Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞)) of THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (11-OH-THC).
- Mean Cmax of 11-OH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-OH-THC.
- Mean AUC(0-t)) of 11-OH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-OH-THC.
- Mean AUC(0-∞) of 11-OH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (11-COOH-THC).
- Mean Cmax of 11-COOH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
- Mean AUC(0-t)) of 11-COOH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
- Mean AUC(0-∞) of 11-COOH-THC.
Measured: 0-48 hours post dose
Pharmacokinetic endpoints of the analyte cannabidiol (CBD).
- Mean Cmax of CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte CBD.
- Mean AUC(0-t) of CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte CBD.
- Mean AUC(0-∞) of CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte 6-hydroxy-cannabidiol (6-OH-CBD).
- Mean Cmax of 6-OH-CBD.
Measured: 0-48 hours.
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
- Mean AUC(0-t) of 6-OH-CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
- Mean AUC(0-∞) of 6-OH-CBD.
Measured: 0-48 hours.
Pharmacokinetic endpoints of the analyte 7-hydroxy-cannabidiol (7-OH-CBD).
- Mean Cmax of 7-OH-CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
- Mean AUC(0-t) of 7-OH-CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
- Mean AUC(0-∞) of 7-OH-CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte 7-carboxy-cannabidiol (7-COOH-CBD).
- Mean Cmax of 7-COOH-CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
- Mean AUC(0-t) of 7-COOH-CBD.
Measured: 0-48 hours
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
- Mean AUC(0-∞) of 7-COOH-CBD.
Measured: 0-48 hours
Secondary outcomes (23)
Pharmacokinetic endpoints of the analyte THC.
- Mean half-life (t1/2) of THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
- Mean time to maximum plasma concentration (tmax) of THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
- Mean apparent clearance of drug from plasma after extravascular administration (CL/F) of THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
- Mean apparent volume of distribution (Vd/F) of THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-OH-THC.
- Mean t1/2 of 11-OH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-OH-THC.
- Mean tmax of 11-OH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
- Mean t1/2 of 11-COOH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
- Mean tmax of 11-COOH-THC.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
- Mean t1/2 of CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
- Mean tmax of CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
- Mean CL/F of CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
- Mean Vd/F of CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
- Mean t1/2 of 6-OH-CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
- Mean tmax of 6-OH-CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
- Mean t1/2 of 7-OH-CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
- Mean tmax of 7-OH-CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
- Mean t1/2 of 7-COOH-CBD.
Measured: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
- Mean tmax of 7-COOH-CBD.
Measured: 0-48 hours post-dose
The incidence of adverse events as a measure of subject safety.
The number of subjects who experienced an adverse event during the study is presented. The time-frame for adverse event reporting was from screening to follow-up visit.
Measured: From screening to follow-up (a maximum of 19 days).
The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline.
The number of subjects with a change in physical and oral examination results indicative of an adverse event, relative to the pre-treatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 19 days)
The number of subjects with a clinically significant change in in 12-lead ECG (electrocardiogram) results, relative to pre-treatment baseline.
The number of subjects with a change in ECG results indicative of an adverse event, relative to the pre-treatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 19 days)
The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline.
The number of subjects with clinically significant changes in serum biochemistry, haematology and urinalysis, relative to the pre-treatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 19 days)
The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline.
The number of subjects with a clinically significant change in vital signs (supine/sitting blood pressure and pulse rate) indicative of an adverse event relative to the pre-treatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 19 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GW Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432612
- Sponsor's protocol ID
- GWCP1450
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, Single-dose Clinical Trial to Assess the Pharmacokinetic (PK) Properties and Tolerability of a Single Oromucosal Dose of 6 Sprays of Sativex® in Patients With Advanced Cancer Currently on Background Step III Opioid Therapy
- ClinicalTrials.gov ID
- NCT02432612
- Acronym / sponsor ID
- GWCP1450
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GW Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy.
Detailed description
This is an open-label, multiple-centre, single dose clinical trial to assess the PK of a single oromucosal dose of Sativex in subjects with advanced cancer who are currently on background Step III opioid therapy.
A minimum of 25 subjects ≥18 years with advanced cancer will be needed for the assessment of the primary objective of the trial. The Screening Visit (Visit 1) will be performed within -10 to -2 days prior to dosing. For the Screening Visit, subjects will attend on an outpatient basis.
Subjects will be checked into the clinical research facility on Day -1 and will be confined to the clinical research facility for the Inpatient/Treatment Period (Day -1 to Day 3) (Visit 2). Subjects will be administered a single oromucosal dose of Sativex on Day 1 (time [t]=0). Fourteen PK blood samples will be taken from Day 1 to Day 3 during Visit 2: one predose sample and 13 postdose samples at the following time points after dosing: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours postdose.
Subjects will be discharged from the clinical research facility after the 48-hour PK blood sample has been taken and final safety assessments are completed. Subjects who discontinue from the trial prior to the completion of the PK blood draws will undergo the safety evaluations scheduled for Day 3.
The Safety Follow-up Call (Visit 3) will be made 7 (+2) days after dosing on Day 1. Subjects with any new adverse events (AEs) or clinical laboratory abnormalities will be asked to return for safety follow-up.
The expected duration for trial participation (including Screening Visit, Inpatient/Treatment Period, and Safety Follow-up Call) for each individual subject is a maximum of 19 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sativex | Experimental | Drug: SativexSativex will be administered by trained, clinical trial personnel, via a pump action oromucosal spray. Sativex will be administered as 2 actuations (sprays) under the tongue or inside the cheeks every 4 minutes until 6 sprays have been administered. Following the administration of the first and second set of 2 actuations, patients will be offered 50 mL water to drink; and following the final set of 2 actuations, 100 mL of water will be offered (i.e., a total of 200 mL water will be offered during the Sativex dosing). There must be a period of at least 2 minutes and no more than 3 minutes between Sativex administration and consumption of water. Patients will not be permitted their regular medication until 2 hours post dose of investigational medicinal product (IMP) to minimize any possible drug interactions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SativexAlso: Nabiximols, GW-1000-02, THC/CBD spraySativex is supplied as a liquid containing 27 mg/mL Δ9-tetrahydrocannabinol (THC) and 25 mg/mL Cannabidiol (CBD) plus peppermint flavoring. Each 100 µL actuation of the pump-action spray delivers 100 µL 27 mg THC and 25 mg CBD. | Drug | Sativex |
Primary outcome
Pharmacokinetic endpoints of the analyte delta 9-tetrahydrocannabinol (THC).
Time frame: 0-48 hours post-dose
• Mean maximum plasma concentration (Cmax) of THC.
Pharmacokinetic endpoints of the analyte THC.
Time frame: 0-48 hours post-dose
• Mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC(0-t)) of THC.
Pharmacokinetic endpoints of the analyte THC.
Time frame: 0-48 hours post-dose
• Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞)) of THC.
Pharmacokinetic endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (11-OH-THC).
Time frame: 0-48 hours post-dose
• Mean Cmax of 11-OH-THC.
Pharmacokinetic endpoints of the analyte 11-OH-THC.
Time frame: 0-48 hours post-dose
• Mean AUC(0-t)) of 11-OH-THC.
Pharmacokinetic endpoints of the analyte 11-OH-THC.
Time frame: 0-48 hours post-dose
• Mean AUC(0-∞) of 11-OH-THC.
Pharmacokinetic endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (11-COOH-THC).
Time frame: 0-48 hours post-dose
• Mean Cmax of 11-COOH-THC.
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
Time frame: 0-48 hours post-dose
• Mean AUC(0-t)) of 11-COOH-THC.
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
Time frame: 0-48 hours post dose
• Mean AUC(0-∞) of 11-COOH-THC.
Pharmacokinetic endpoints of the analyte cannabidiol (CBD).
Time frame: 0-48 hours
• Mean Cmax of CBD.
Pharmacokinetic endpoints of the analyte CBD.
Time frame: 0-48 hours
• Mean AUC(0-t) of CBD.
Pharmacokinetic endpoints of the analyte CBD.
Time frame: 0-48 hours
• Mean AUC(0-∞) of CBD.
Pharmacokinetic endpoints of the analyte 6-hydroxy-cannabidiol (6-OH-CBD).
Time frame: 0-48 hours.
• Mean Cmax of 6-OH-CBD.
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
Time frame: 0-48 hours
• Mean AUC(0-t) of 6-OH-CBD.
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
Time frame: 0-48 hours.
• Mean AUC(0-∞) of 6-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-hydroxy-cannabidiol (7-OH-CBD).
Time frame: 0-48 hours
• Mean Cmax of 7-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
Time frame: 0-48 hours
• Mean AUC(0-t) of 7-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
Time frame: 0-48 hours
• Mean AUC(0-∞) of 7-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-carboxy-cannabidiol (7-COOH-CBD).
Time frame: 0-48 hours
• Mean Cmax of 7-COOH-CBD.
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
Time frame: 0-48 hours
• Mean AUC(0-t) of 7-COOH-CBD.
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
Time frame: 0-48 hours
• Mean AUC(0-∞) of 7-COOH-CBD.
23 secondary outcomes
Pharmacokinetic endpoints of the analyte THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-OH-THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-OH-THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
Time frame: 0-48 hours post-dose
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
Time frame: 0-48 hours post-dose
The incidence of adverse events as a measure of subject safety.
Time frame: From screening to follow-up (a maximum of 19 days).
The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline.
Time frame: From screening to follow-up (a maximum of 19 days)
The number of subjects with a clinically significant change in in 12-lead ECG (electrocardiogram) results, relative to pre-treatment baseline.
Time frame: From screening to follow-up (a maximum of 19 days)
The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline.
Time frame: From screening to follow-up (a maximum of 19 days)
The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline.
Time frame: From screening to follow-up (a maximum of 19 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sativex in people with Advanced Cancer, run by GW Pharmaceuticals Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic endpoints of the analyte delta 9-tetrahydrocannabinol (THC). (time frame: 0-48 hours post-dose). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.