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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Johann
de Bono
johann.debono@icr.ac.uk
IIT
Team
iitteam@icr.ac.uk
IIT
Team
iitteam@icr.ac.uk
Malignant neoplasms of male genital organs
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC). SX-682 blocks two key molecules (CXCR1 and CXCR2) involved in the inflammation pathway,which can cause resistance to endocrine therapy for this disease. ASpiRE will succeed ACE,which investigated the combination of the CXCR2 inhibitor AZD5069 with enzalutamide in mCRPC. CXCR2 is a receptor to chemokines. Chemokines are small chemical messengers released by cells that influence the behaviour of immune cells. In prostate cancer,CXCR2 signalling leads to the migration of a set of immune cells called myeloid cells,which work together with cancer cells and lead to cancer progression and resistance to therapy. In ACE,it was demonstrated that blocking CXCR2 with AZD5069 reduced myeloid cells in tumours and improved the efficacy of enzalutamide. However,in this study,it was also found that the effect of this inhibition may be reduced due to the presence of another chemokine receptor known as CXCR1. As such,blocking both CXCR1 and CXCR2 might prove to be more beneficial than just blocking CXCR2. ASpiRE will thus investigate the effect of SX-682 in reversing resistance to endocrine therapy in combination with Apalutamide.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1. Surgery,chemotherapy,or other anti-cancer therapy within 4 weeks prior to trial entry/randomisation into the study (with the exception of abiraterone,enzalutamide,Apalutamide or darolutamide). Any other therapy for prostate cancer,other than gonadotropin releasing hormone analogue therapy,such as progesterone,medroxyprogesterone,progestins or 5-alpha reductase inhibitors,must be discontinued at least 2 weeks before the first dose of the study drug. 2. Participation in another interventional clinical trial of an IMP within 4 weeks prior to trial entry. Participation in trials of licensed medications is allowed provided the medication is not a prohibited concomitant medication. 3. Prior limited field radiotherapy within 2 weeks and wide field radiotherapy within 4 weeks prior to trial entry. 4. Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism. 5. History of seizures or other predisposing factors including,but not limited to,underlying brain injury,stroke,primary brain tumours,brain metastases and leptomeningeal disease,or alcoholism. 6. Malabsorption syndrome or other condition that would interfere with enteral absorption. 7. Any of the following cardiac criteria: • QTcF interval > 470 msec. • Clinically important abnormalities including rhythm,conduction,or electrocardiogram (ECG) changes (left bundle branch block,third degree heart block). • Factors predisposing to QT prolongation including heart failure,hypokalaemia,congenital long QT syndrome,family history of prolonged QT syndrome,unexplained sudden death (under 40) and concomitant medications known to prolong QT interval. • Coronary artery bypass,angioplasty,vascular stent,myocardial infarction,angina,congestive heart failure (NYHA ≥ grade 2) i or transient ischaemic attack) in the last 6 months (see appendix 4 for NYHA scale). • Uncontrolled hypotension (systolic blood pressure < 90mmHg). • Uncontrolled hypertension on optimal medical management. 8. Clinically significant history of liver disease (Child-Pugh B or C,viral or other hepatitis,current alcohol abuse or cirrhosis). 9. Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect interpretation of the results or renders the patients at high risk from treatment complications,e.g.,patients with a hypersensitivity to the active substance or any of the excipients. 10. Malignancy other than prostate cancer within 5 years of trial entry except for adequately treated basal cell carcinoma. 11. Unresolved significant toxicity from prior therapy (except alopecia and grade 1 peripheral neuropathy). 12. Inability to comply with study and follow-up procedures. 13. Predominantly small cell or neuroendocrine differentiated (> 20% of cells) prostate cancer. 14. Immunocompromised patients. 15. Active or uncontrolled autoimmune disease requiring corticosteroid therapy. 16. History of thromboembolic disease within 12 months of commencement of trial. 17. At high-risk because of non-malignant systemic disease including active infection and any serious concurrent illness. 18. Any known intolerance to Apalutamide,SX-682,or to any constituents. 19. Symptoms of COVID-19 and/or documented COVID-19 infection. 20. Is taking any of the following prohibited medications: • Aminophylline/theophylline • Atypical antipsychotics (eg,clozapine,olanzapine,risperidone,ziprasidone) • Buproprion • Lithium • Meperidine and pethidine • Phenothiazine antipsychotics (eg,chlorpromazine,mesoridazine,thioridazine) • Tricyclic and tetracyclic antidepressants (eg,amitriptyline,desipramine,doxepin,imipramine,maprotiline,mirtazapine • Warfarin or coumarin-like anticoagulants 21. History of previous non-infectious pneumonitis requiring steroid treatment,or active non-infectious pneumonitis. 22. History of previous severe drug induced severe cutaneous reaction including but not limited to Steven-Johnson’s syndrome/toxic epidermal necrolysis,drug reaction with eosinophilia and systemic symptoms (DRESS).
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Institute of Cancer Research: Royal Cancer Hospital and funded by PROSTATE CANCER UK .
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Read full details
for Trial ID: CPMS 58181
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