Could Aspirin and Ticagrelor be used to help stop the spread of cancer?
- Conditions
- Solid cancer metastasisTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004049-29-GB
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Healthy Volunteers
Provision of informed consent prior to any study specific procedures
Male or female aged 18-85
Adequate level of spoken and written English to give informed consent
Use of 2 types of contraception for duration of involvement
Check of TOPS reveals no over-volunteering
Use of appropriate contraceptive measures
Cardiovascular patients
Provision of informed consent prior to any study specific procedures
Male or female aged 18-85
Adequate level of spoken and written English to give informed consent
Use of appropriate contraceptive measures
Generic cancer patients – for blood sampling only
Provision of informed consent prior to any study specific procedures
Male or female aged 18-85
Any metastatic solid tumour
Adequate level of spoken and written English to give informed consent
Breast Cancer patients
Provision of informed consent prior to any study specific procedures
Female aged 18-85
WHO performance status 0-2
Presence of metastases in at least one organ/system eg. Liver, lungs, lymphadenopathy.
Haematological and biochemical indices within the ranges shown below:
Haemoglobin (Hb) =10g/dl,
Neutrophils =2000/µl,
Platelet count = 100.000/µl and =500,000/ µl,
AST or ALT = 3 ULN, alkaline phosphatase = 2x ULN,
Serum Bilirubin = 1.5 ULN,
Creatinine Clearance = 45ml/min
Adequate level of spoken and written English to give informed consent
Use of 2 types of contraception for duration of involvement
Use of appropriate contraceptive measures
Colorectal Cancer patients
Provision of informed consent prior to any study specific procedures
Male or female aged 18-85
Who performance status 0-2
Presence of metastases in at least one organ/system eg. Liver, lungs, lymphadenopathy.
Haematological and biochemical indices within the ranges shown below:
Haemoglobin (Hb) =10g/dl,
Neutrophils = 2000/µl,
Platelet count = 100.000/µl and =500,000/ µl,
AST or ALT = 3 ULN, alkaline phosphatase = 2x ULN,
Serum Bilirubin = 1.5 ULN,
Creatinine Clearance = 45ml/min
Adequate level of spoken and written English to give informed consent
Use of 2 types of contraception for duration of involvement
Use of appropriate contraceptive measures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Previous history of intracranial bleed
Any pre-existent bleeding disorder
History of gastrointestinal bleeding requiring transfusion in the last year or peptic ulceration in the last year
Current prescription of any antiplatelet therapy for another clinical indication
Current anticoagulation
Currently receiving cytotoxic chemotherapy
Currently receiving tamoxifen (other endocrine therapies are allowed)
More than 3 lines of chemotherapy for metastatic disease
Current treatment with NSAIDS
Current or long term use of oral corticosteroids
Previous history of aspirin or Ticagrelor intolerance.
Pregnancy or breast feeding
History of other malignancy less than 5 years before the diagnosis of breast or colorectal cancer, EXCLUDING the following: Non-melanoma skin cancer, in situ carcinoma of the cervix treated surgically with curative intent, other malignant tumours that have been treated curatively and patient is deemed disease-free
Any other physical condition which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including patients with a high risk of mortality from another cause within the trial treatment period.
Inadequate level of spoken and written English to give informed consent
Pregnancy / trying to get pregnant. Pregnancy is an absolute dicontinuation criteria.
Use of strong CYP 3A4 inhibiting medicines including Boceprevir,Clarithromycin,Cobicistat,HIV-protease inhibitors boosted with ritonavir,nefazodone, atazanavir, Itraconazole,Ketoconazole,Nelfinavir,Ritonavir,Saquinavir,Telaprevir,Telithromycin,
Voriconazole
Patients with gout
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does Ticagrelor effect platelets in ways that are likely to reduce the spread of cancer in the blood of people taking Ticagrelor (i.e. in vivo), and does Ticagrelor seem to have more effect than Aspirin.<br>;Secondary Objective: Does dual therapy with both Aspirin and Ticagrelor have more effect on pro-metastatic tumour cell platelet interactions than monotherapy with either drug alone;Primary end point(s): This will not be a clinical endpoint study. The primary outcome will be an assessment of the differential effect of the study drugs on tumour cell platelet interaction assays in vitro with each of the study drugs;Timepoint(s) of evaluation of this end point: Comparison will be made of in vitro tumour-cell platelet interactions prior to treatment with the same assays repeated after 2-weeks treatment with each study drug alone. There will be a 2-week washout period after the first drug and patients will be randomised as to which study drug they receive first.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): This will not be a clinical endpoint study. The secondary outcome will be an assessment of the differential effect of the study drugs given in combination on tumour cell platelet interaction assays in vitro ;Timepoint(s) of evaluation of this end point: Comparison will be made of in vitro tumour-cell platelet interactions prior to treatment, and following administration of single study drug therapy with both study drugs given in combination.