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Be willing and able to provide written informed consent for the trial |
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Be aged 18 or over at the day of signing consent |
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histologically or cytologically confirmed diagnosis of neuroendocrine tumour |
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archival tissue block available |
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disease that can be readily biopsied by ultrasound guidance (n=5) |
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Ki67 < 55%(only patients with well differentiated grade 1-3 NETs will be included in the study as patients with poorly differentiated grade 3 NETs have a prognosis of less than 6 months) |
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Progression or intolerance to first line therapy including somatostatin analogues Version 3.6 - 4th Novermber 2021 IRAS ID 285903 Page 11 of 69 |
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ECOG Performance status 0 - 2 |
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Tumoural uptake on [68Ga]-DOTA-TATE greater than background liver |
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Measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions |
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Adequate organ function (see table 4) |
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Women of childbearing potential must be willing to use a highly effective method of contraception as outlined in Appendix 4 for the course of the study through 6 months after the last dose of Investigational Medicinal Product (IMP) |
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Note: Abstinence is acceptable if this is the usual lifestyle and preferred |
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contraception for the subjects |
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Sexually active males must agree to use an adequate method of contraception as outlined in Appendix 4 starting with the first dose of IMP through 6 months after the last dose of study therapy |
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Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception |
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for the subject |
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Previous treatment with either study medication and/or known hypersensitivity to the
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study medication
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Serious concurrent medical illness, including serious active infection
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History of organ transplant
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Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is
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required unless mandated by local health authority
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Has a known history of active Bacillus Tuberculosis (TB)
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Has known active CNS metastases and/or carcinomatous meningitis. Participants with
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previously treated brain metastases may participate provided they are radiologically
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stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging
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(note that the repeat imaging should be performed during study screening), clinically
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stable and without requirement of steroid treatment for at least 14 days prior to
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first dose of study treatment
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Bleeding or thrombotic disorders or subjects at risk for severe haemorrhage
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Is currently participating and receiving therapy or has participated or is
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participating in a study of an IMP or used an investigational device within 4 weeks of
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the first dose of IMP
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Has a known additional malignancy that is progressing or requires active treatment
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Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
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skin that has undergone potentially curative therapy or in situ cervical cancer
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Has a history or current evidence of any condition, therapy, or laboratory abnormality
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that might confound the results of the trial, interfere with the subject's
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participation for the full duration of the trial, or is not in the best interest of
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the subject to Version 3.6 - 4th Novermber 2021 IRAS ID 285903 Page 12 of 69
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participate, in the opinion of the treating Principal Investigator (PI)
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Has known psychiatric or substance abuse disorders that would interfere with
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cooperation with the requirements of the trial
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Is pregnant or breastfeeding, or expecting to conceive or father children within the
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projected duration of the trial, starting with the screening visit through to 6 months
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after the last dose of IMP
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Has received a live vaccine within 30 days of first dose of ASTX727 administration
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Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines
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and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live
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attenuated vaccines, and are not allowed
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Has received prior radiotherapy within 2 weeks of start of study treatment
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Participants must have recovered from all radiation-related toxicities, not require
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corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted
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for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease and
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stereotactic radiotherapy to the CNS
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Other clinically significant co-morbidities that could compromise the subject's
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participating in the study
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