[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574090":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":53,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":21,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":80,"whyStopped":21,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Treatment Arm - AZD6738","EXPERIMENTAL","Part A - oral dose of Ceralasertib and a radiolabelled IV microdose of \\[14C\\]-Ceralasertib Part B - oral dose of \\[14C\\]-Ceralasertib",[13,14],"Drug: [14C] AZD6738","Drug: AZD6738 \u002F ceralasertib",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","[14C] AZD6738","radiolabeled AZD6738 \u002F ceralasertib",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"AZD6738 \u002F ceralasertib","Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine\u002Fthreonine-specific protein kinase ATR",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[33,45],{"facility":34,"status":21,"city":35,"state":21,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":21},"Research Site","Liverpool","L7 8YA","United Kingdom","UK",{"type":40,"coordinates":41},"Point",[42,43],-2.97794,53.41058,{"lat":43,"lon":42},{"facility":34,"status":21,"city":46,"state":21,"zip":47,"country":37,"countryCode":38,"cosmosGeoPoint":48,"geoPoint":52,"contacts":21},"London","NW1 2PG",{"type":40,"coordinates":49},[50,51],-0.12574,51.50853,{"lat":51,"lon":50},{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100574090","phase-1-human-adme-study-of-14c-ceralasertib-azd6738-and-absolute-bioavailability-of-ceralasertib-100574090",false,"NCT06754761","Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib","A Phase I, Open-label Study to Assess the Absolute Bioavailability of Ceralasertib (AZD6738) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Ceralasertib in Patients With Non-small Cell Lung Cancer, Ovarian Cancer, or Endometrial Cancer","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.\n\n   Type of Participant and Disease Characteristics\n2. Sufficient ECOG performance status, life expectancy, and ability to swallow and retain oral medication\n3. Adequate organ and marrow function\n4. Willingness and ability to comply with study and follow-up procedures.\n5. Able and willing to stay in hospital for specified residential periods following administration of Ceralasertib\u002F\\[14C\\]-Ceralasertib\n6. Regular bowel movements\n7. Participants with NSCLC must have appropriately documented NSCLC diagnosis, mutation status, treatment history, and disease status according to protocol-specified eligibility criteria\n8. Participants with Ovarian cancer must have appropriately documented ovarian cancer diagnosis, mutation status, treatment history, and disease status according to protocol-specified eligibility criteria 9. Participants with Endometrial cancer must have appropriately documented endometrial cancer diagnosis, treatment history, and disease status according to protocol-specified eligibility criteria 10. Sex and Contraceptive\u002FBarrier Requirements: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 11. Informed Consent: patient must be capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  1. History of Diagnosis of protocol-specified medical conditions\n  2. Spinal cord compression or brain metastasis prior to start of study intervention unless asymptomatic and stable\n  3. Persistent toxicities (CTCAE Grade ≥ 2), with the exception of alopecia and vitiligo, caused by previous anticancer therapy.\n  4. History of allogenic organ transplant or autoimmune or inflammatory disorders requiring use of immunosuppressive medications with some protocol specified conditions\u002Fexceptions\n  5. Any medical or surgical condition that would preclude adequate absorption of Ceralasertib\n  6. Inadequate cardiac function \u002F status or other cardiovascular diseases\n  7. Participants with active infection requiring systemic antibiotics, antifungal or antiviral drugs\n  8. Any evidence of severe or uncontrolled systemic disease, as judged by the investigator that would make it undesirable for the participant to participate in the study or would jeopardise compliance with the protocol\n  9. Protocol-specified prior\u002Fconcomitant therapy exclusions\n  10. Protocol-specified prior\u002Fconcurrent clinical study experience\n  11. Other Exclusions including but not limited to tobacco\u002Fnicotine and\u002For alcohol use, or drug\u002Falcohol abuse history\n  12. Not currently pregnant, breast-feeding, or planning to become pregnant","ALL","18 Years",{"count":65,"type":66},8,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","This is an open-label, two-part study in participants with NSCLC, ovarian cancer, or endometrial cancer and will be conducted at multiple study sites.\n\nParticipants will be assessed for study eligibility prior to admission to the study site.\n\nPart A will assess the absolute bioavailability, determine the excretory routes of \\[14C\\]-Ceralasertib, and evaluate the PK parameters of a Ceralasertib oral dose and a radiolabelled IV microdose of \\[14C\\]-Ceralasertib.\n\nParticipants will be admitted to the study site pre-dose Part A and will remain at the study site for excreta (urine and faeces) collections, PK sampling and safety assessments. A washout period days will be observed between dosing in Part A and Part B. Part B will assess the ADME of \\[14C\\]-Ceralasertib.\n\nParticipants will be readmitted to the study site for Part B and will remain at the study site for excreta (urine, faeces, and any vomitus) collections, PK sampling, and safety assessments.\n\nParticipants will return to the study site for a Follow-up Visit after the last dose of Ceralasertib which will include routine safety assessments.\n\nAfter the completion of Parts A and B, and following the Follow-up Visit, participants may be allowed further access to Ceralasertib if in the opinion of the investigator and medical monitor they may derive clinical benefit.",[72],"Neoplasm",[74,75,76,77,78,79],"non-small cell lung cancer","ovarian cancer","endometrial cancer","hADME, bioavailability","AZD6738","ceralasertib","NOT_YET_RECRUITING","2024-12-23",{"date":83,"type":84},"2025-01-01","ACTUAL",{"date":86,"type":66},"2025-01-17",{"date":88,"type":66},"2025-08-08",{"name":5,"class":6},2]