- Trial ID:
- Michael Kosty
- 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
- 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- 3. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:
- Provision of informed consent for genetic research prior to collection of sample.
- Provision of informed consent for biomarker research prior to collection of sample.
If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.
- 1. Has a known additional malignancy that has had progression or has required active treatment in the last 5 years.
- 2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).
- 3. Clinically significant cardiovascular disease Association Class II-IV heart failure or cardiac ejection fraction measurement of <50% during screening as assessed by echocardiography or multigated acquisition scan.
- 4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.
- 5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis).
- 6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)).
- 7. History of uncontrolled pituitary or adrenal dysfunction.
- 8. Active infection or other medical condition that would make prednisone/prednisolone use contraindicated.
- 9. Any chronic medical condition requiring a systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day.
- AstraZeneca Clinical Study Information Center
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.