Solid cancer metastasis
Conditions
Interventions
Trade Name: Aspirin
Product Name: Aspirin
Product Code: Acetylsalicylic Acid
Pharmaceutical Form: Tablet
INN or Proposed INN: Aspirin
CAS Number: 50-78-2
Concentration unit: mg/g milligram(s)/gram
Co
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed