Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02423239 : A Study of Dexanabinol in Combination With Chemotherapy in Patients With Advanced Tumours
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria

1. (i) Parts 1 and 2b (dexanabinol combination): Patients with selected
histologically, cytologically or radiologically confirmed tumours that are advanced,
metastatic and/or progressive, and eligible for 1st line chemotherapy.

- HCC only: patient with Child-Pugh A stage.

- Pancreatic cancer only: patients diagnosed with adenocarcinoma (i.e. pancreatic
cancer patients with islet cell neuroplasms are excluded).

(ii) Part 2a (dexanabinol monotherapy): Patients with histologically, cytologically
or radioloigically confirmed tumours that are advanced, metastatic and/or
progressive, for whom there is no effective standard therapy available.

- Pancreatic cancer only: patients diagnosed with adenocarinoma (i.e. pancreatic
cancer patients with islet cell neuroplasms are excluded).

2. Adults patients defined by age ? 18 years.

3. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) or 0 or 1.

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.

5. (i) Parts 1 and 2b: Measureable disease assessed by appropriate method for each
tumour type e.g. RECIST 1.1 (Eisenhauer, et al. 2009).

(ii) Part 2a: Evaluable disease, either measureable on imaging, or with informative
tumour marker(s).

6. Laboratory values at Screening:

- Absolute neutrophil count ? 1.5 x 109L;

- Platelets ? 100 x 109/L;

- Total bilirubin; in 1st line pancreatic cancer (part 1 and 2b) ?1.25 times the
upper limit of normal (ULN); all other tumour types and settings except HCC ?1.5
times ULN; in HCC ?5 times the ULN

- AST (SGOT) ?2.5 times the ULN (when there is no liver tumour involvement) up to

- 5 times the ULN (in patients with liver tumour involvement);

- ALT (SGPT) ?2.5 times the ULN (when there is no liver tumour involvement) up to

- 5 times the ULN (in patients with liver tumour involvement);

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

- Negative hCG test in women of childbearing potential

7. Have a life expectancy of >3 months.

8. 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.

9. 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. Known brain metastases.

4. (i) Parts 1 and 2b (dexanabinol combination): Prior systemic chemotherapy.

(ii) Part 2a (dexanabinol monotherapy): Chemotherapy or radiotherapy within 4 weeks
(6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1, Day 1 for solid tumours
(with the exception of hydroxyurea, which must be discontinued at least 24 hours
prior to Cycle 1, Day 1). Localised palliative radiotherapy is permitted for symptom
control.

5. Major surgery within 4 weeks prior to Cycle 1, Day 1; bone marrow transplant within
100 days prior to Cycle 1, Day 1.

6. Known human immunodeficiency virus positivity.

7. Active hepatitis B or C or other active liver disease (other than malignancy)
(applies to all tumours types enrolled except HCC).

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

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

10. 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02423239      |      Link to official Clinicaltrials.gov listing
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