Solid TumourPhase 1NCT01489826

A Phase 1 Study of Dexanabinol in Patients With Advanced Solid Tumours

A Phase 1 study testing Dexanabinol and Cremophor in people with Solid Tumour, run by e-Therapeutics PLC at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a trial of Dexanabinol in patients with advanced solid tumours. The purposes of this protocol are to study different doses of the study drug to determine the maximum safe dose and to further understand the safety of the study drug; to understand what the body does to the study drug; to understand what… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumour
What is being tested?: Dexanabinol and Cremophor
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesUnited Kingdom
Study dates: Jan 2012to Jul 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Adult patients defined by age ≥18 years.
Patients with histologically or cytologically confirmed solid tumours that are advanced, metastatic and or progressive, for whom there is no effective standard therapy available.
Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.
Any acute or chronic adverse effects of prior chemotherapy or radiotherapy have resolved to < Grade 2 as determined by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria, with the exception of alopecia.
Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Eisenhauer, et al. 2009).
Laboratory values at Screening:

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Absolute neutrophil count ≥1.5 x 109/L;
Platelets ≥100 x 109/L;
Total bilirubin <1.5 times the upper limit of normal;
Aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal;
Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
Estimated glomerular filtration rate (GFR) of >50 mL/min (based on the Wright formula (Wright, et al. 2001); and
Negative human chorionic gonadotropin (hCG) test in women of childbearing potential (defined as women ≤50 years of age or history of amenorrhea for ≤12 months prior to study entry). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 1 month after final administration of Dexanabinol, or the patient must be surgically sterile (with documentation in the patient's medical records).
If there is a history of treated brain metastases, these must have been clinically stable for ≥4 weeks prior to enrollment.
Have a life expectancy of >3 months.
Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
Be willing and able to comply with the study protocol procedures.

Who cannot join

Patient is pregnant or breast feeding.
History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months of Cycle 1, Day 1.
Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1, Day 1. Localised palliative radiotherapy is permitted for symptom control.
Major surgery within 6 weeks prior to Cycle 1, Day 1.
Known human immunodeficiency virus positivity.
Active hepatitis B or C or other active liver disease (other than malignancy).

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Use of any investigational agents within 4 weeks of Cycle 1, Day 1.
Any active, clinically significant, viral, bacterial, or systemic fungal infection within 4 weeks prior to Cycle 1, Day 1.
History of significant chronic or recurrent infections requiring treatment or any uncontrolled intercurrent illness that would jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

The Beatson West of Scotland Cancer Centre,
Glasgow, G12 0YN
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Northern Centre for Cancer Care, Freeman Hospital, Newcastle-upon-Tyne, UK
Newcastle upon Tyne, Tyne and Wear, NE7 7DN

Other trials in United Kingdom

About this study

Official title: A Phase 1, Pharmacokinetically-Guided, Dose Escalation Study to Assess the Safety and Tolerability of Dexanabinol in Patients With Advanced Solid Tumours

Dexanabinol is a synthetic cannabinoid derivative with reduced psychotropic potential which was initially investigated as a neuroprotective agent. Because of its method of action however it is thought that it may have the effect of destroying cancer cells by reducing the level of control on networks that prevent cancer cells dying.

Conditions: Solid Tumour
Being tested: Dexanabinol, Cremophor
Keywords: Cancer
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexanabinolDrug
Also called ETS2101, HU-211
Patients will (initially) be given a slow intravenous (i.v.) infusion of Dexanabinol over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle.
CremophorOther
Drug vehicle.

Study groups in NCT01489826
Study group	Role	What they receive
Dexanabinol 2 mg/kg	Experimental	Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol 3 mg/kg	Experimental	Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol 6 mg/kg	Experimental	Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol 12 mg/kg	Experimental	Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol 15 mg/kg	Experimental	Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol 22 mg/kg	Experimental	Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol 30 mg/kg	Experimental	Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol 36 mg/kg	Experimental	Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor
Dexanabinol Expansion Phase	Experimental	Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) Receives: Drug: Dexanabinol; Other: Cremophor

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Experiencing Dose Limiting Toxicity (DLT)
Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD).
3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no DLT has occurred. Upon occurrence of the first DLT within a cohort, an additional 3 patients were to be added to that cohort. For a six patient cohort, all 6 patients were to have completed their first dexanabinol treatment cycle with no more than 1 DLT before dose escalation to the next cohort. If 2 or more DLTs occur in a cohort, the next lower dose level will be declared the MTD.
DLTs will be graded for severity based on the National Cancer Institute (NCI) Common Terminology Criteria version 4.03.
Measured: Each patient will be followed for 22 days

Secondary outcomes (10)

Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 1
Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 1.
Measured: Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 1
Mean Cmax of Dexanabinol on Cycle 1 Day 1
Measured: Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Number of Adverse Events (AEs)
AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials
Measured: 30 +/-3 days from the end of the last infusion
Progression Free Survival
Tumour response evaluation using RECIST 1.1. (Assessment by CT scan or MRI).
Measured: At Screening and after every 2 cycles of treatment (+/-1 week)
Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 8
Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 8.
Measured: Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Area Under Curve (AUC) of Cremophor on Cycle 1 Day 1
Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 1.
Measured: Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Area Under Curve (AUC) of Cremophor on Cycle 1 Day 8
Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 8.
Measured: Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 8
Mean Cmax of Dexanabinol on Cycle 1 Day 8
Measured: Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 1
Mean Cmax of Cremophor on Cycle 1 Day 1
Measured: Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 8
Mean Cmax of Cremophor on Cycle 1 Day 8
Measured: Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jul 2015

First posted12 Dec 2011 (estimated)
Study startJan 2012
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Solid TumourStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01489826
Sponsor's protocol ID: ETS2101-001
Status last verified: Oct 2016
First submitted: 7 Dec 2011
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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All Solid Tumour trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Pharmacokinetically-Guided, Dose Escalation Study to Assess the Safety and Tolerability of Dexanabinol in Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT01489826
Acronym / sponsor ID: ETS2101-001
Conditions: Solid Tumour
Keywords: Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: e-Therapeutics PLCIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 12 Dec 2011 (estimated)
Results: Posted 18 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Dexanabinol 2 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol 3 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol 6 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol 12 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol 15 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol 22 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol 30 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol 36 mg/kg	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Dexanabinol Expansion Phase	Experimental	Drug: Dexanabinol, Other: CremophorDexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Adult patients defined by age ≥18 years.
Patients with histologically or cytologically confirmed solid tumours that are advanced, metastatic and or progressive, for whom there is no effective standard therapy available.
Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.
Any acute or chronic adverse effects of prior chemotherapy or radiotherapy have resolved to < Grade 2 as determined by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria, with the exception of alopecia.
Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Eisenhauer, et al. 2009).

Key exclusion criteria (9 listed)

Patient is pregnant or breast feeding.
History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months of Cycle 1, Day 1.
Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1, Day 1. Localised palliative radiotherapy is permitted for symptom control.
Major surgery within 6 weeks prior to Cycle 1, Day 1.
Known human immunodeficiency virus positivity.

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
DexanabinolAlso: ETS2101, HU-211Patients will (initially) be given a slow intravenous (i.v.) infusion of Dexanabinol over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle.	Drug	Dexanabinol 12 mg/kg, Dexanabinol 15 mg/kg, Dexanabinol 2 mg/kg, Dexanabinol 22 mg/kg, Dexanabinol 3 mg/kg, Dexanabinol 30 mg/kg, Dexanabinol 36 mg/kg, Dexanabinol 6 mg/kg, Dexanabinol Expansion Phase
CremophorDrug vehicle.	Other	Dexanabinol 12 mg/kg, Dexanabinol 15 mg/kg, Dexanabinol 2 mg/kg, Dexanabinol 22 mg/kg, Dexanabinol 3 mg/kg, Dexanabinol 30 mg/kg, Dexanabinol 36 mg/kg, Dexanabinol 6 mg/kg, Dexanabinol Expansion Phase

Primary outcome

Number of Patients Experiencing Dose Limiting Toxicity (DLT)
Time frame: Each patient will be followed for 22 days
Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD). 3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no DLT has occurred. Upon occurrence of the first DLT within a cohort, an additional 3 patients were to be added to that cohort. For a six patient cohort, all 6 patients were to have completed their first dexanabinol treatment cycle with no more than 1 DLT before dose escalation to the next cohort. If 2 or more DLTs occur in a cohort, the next lower dose level will be declared the MTD. DLTs will be graded for severity based on the National Cancer Institute (NCI) Common Terminology Criteria version 4.03.

10 secondary outcomes

Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 1
Time frame: Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 1
Time frame: Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Number of Adverse Events (AEs)
Time frame: 30 +/-3 days from the end of the last infusion
Progression Free Survival
Time frame: At Screening and after every 2 cycles of treatment (+/-1 week)
Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 8
Time frame: Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Area Under Curve (AUC) of Cremophor on Cycle 1 Day 1
Time frame: Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Area Under Curve (AUC) of Cremophor on Cycle 1 Day 8
Time frame: Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 8
Time frame: Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 1
Time frame: Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.
Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 8
Time frame: Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Results and safety

Results posted to the registry on 18 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexanabinol 2 mg/kg	3	3
Dexanabinol 3 mg/kg	3	3
Dexanabinol 6 mg/kg	3	3
Dexanabinol 12 mg/kg	7	7
Dexanabinol 15 mg/kg	3	3
Dexanabinol 22 mg/kg	3	3
Dexanabinol 30 mg/kg	9	9
Dexanabinol 36 mg/kg	3	3
Dexanabinol Expansion Phase	6	6

Primary outcome: Number of Patients Experiencing Dose Limiting Toxicity (DLT)

Time frame: Each patient will be followed for 22 days. Number. Unit: Number of patients with DLT

Measure	Dexanabinol 2 mg/kg n = 3	Dexanabinol 3 mg/kg n = 3	Dexanabinol 6 mg/kg n = 3	Dexanabinol 12 mg/kg n = 7	Dexanabinol 15 mg/kg n = 3	Dexanabinol 22 mg/kg n = 3	Dexanabinol 30 mg/kg n = 9	Dexanabinol 36 mg/kg n = 3	Dexanabinol Expansion Phase n = 6
Value	0	0	0	1	0	0	0	2	0

Population analysed: Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the MTD (highest dose it is safe to give patients) or alternatively the Maximum Administered Dose(MAD). DLT evaluation in 3 to 6 patients at end of 1 treatment cycle

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexanabinol 2 mg/kg	3 of 3 (100%)	3 of 3 (100%)	Not reported
Dexanabinol 3 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Dexanabinol 6 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Dexanabinol 12 mg/kg	2 of 7 (28.6%)	7 of 7 (100%)	Not reported
Dexanabinol 15 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Dexanabinol 22 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Dexanabinol 30 mg/kg	5 of 9 (55.6%)	9 of 9 (100%)	Not reported
Dexanabinol 36 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Dexanabinol Expansion Phase	2 of 6 (33.3%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ruth Plummer, MD principal investigator

Northern Centre for Cancer Care, Freeman Hospital, Newcastle-upon-Tyne, UK

Alan Anthoney, MD principal investigator

Leeds Cancer Centre at St. James's University Hospital

Jeff Evans, MD principal investigator

The Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexanabinol and Cremophor in people with Solid Tumour, run by e-Therapeutics PLC at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 18 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Experiencing Dose Limiting Toxicity (DLT) (time frame: Each patient will be followed for 22 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01489826.

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 9 Feb 2017.