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

Phase 1
18 Years
Open (Enrolling)
Solid Tumour

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Trial Information

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

Inclusion Criteria:

1. Adult patients defined by age ≥18 years.

2. Patients with histologically or cytologically confirmed solid tumours that are
advanced, metastatic and or progressive, for whom there is no effective standard
therapy available.

3. Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2 (Appendix A).

4. Any acute or chronic adverse effects of prior chemotherapy or radiotherapy have
resolved to < Grade 2 as determined by CTCAE v4.03 criteria, with the exception of
alopecia (Appendix B).

5. Evaluable disease, either measurable on imaging, or with informative tumour
marker(s), as assessed by RECIST 1.1 (Eisenhauer, et al. 2009).

6. Laboratory values at Screening:

- Absolute neutrophil count ≥1.5 x 109/L;

- Platelets ≥100 x 109/L;

- Total bilirubin <1.5 times the upper limit of normal;

- AST (SGOT) ≤2.5 times the upper limit of normal;

- ALT (SGPT) ≤2.5 times the upper limit of normal;

- Estimated GFR of >50 mL/min (based on the Wright formula (Wright, et al. 2001);

- Negative 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).

7. If there is a history of treated brain metastases, these must have been clinically
stable for ≥4 weeks prior to enrollment.

8. Have a life expectancy of >3 months.

9. 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procedures, with the understanding that the consent may be withdrawn by the patient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.

10. Be willing and able to comply with the study protocol procedures.

Exclusion Criteria:

1. Patient is pregnant or breast feeding.

2. History of clinically significant cardiac condition, including ischemic cardiac
event, myocardial infarction or unstable cardiac disease within 3 months of Cycle 1,
Day 1.

3. 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

4. Major surgery within 6 weeks prior to Cycle 1, Day 1.

5. Known human immunodeficiency virus positivity.

6. Active hepatitis B or C or other active liver disease (other than malignancy).

7. Use of any investigational agents within 4 weeks of Cycle 1, Day 1.

8. Any active, clinically significant, viral, bacterial, or systemic fungal infection
within 4 weeks prior to Cycle 1, Day 1.

9. 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

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). 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 Dose Limiting Toxicity (DLT) has occurred. DLTs will be graded for severity based on the NCI Common Terminology Criteria version 4.03

Outcome Time Frame:

Each patient will be followed for 22 days

Safety Issue:


Principal Investigator

Ruth Plummer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Solid Tumour
  • Neoplasms