Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06754761
Eligibility Criteria:
Inclusion Criteria:
* Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1. 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.
Type of Participant and Disease Characteristics
2. Sufficient ECOG performance status, life expectancy, and ability to swallow and retain oral medication
3. Adequate organ and marrow function
4. Willingness and ability to comply with study and follow-up procedures.
5. Able and willing to stay in hospital for specified residential periods following administration of Ceralasertib/\[14C\]-Ceralasertib
6. Regular bowel movements
7. Participants with NSCLC must have appropriately documented NSCLC diagnosis, mutation status, treatment history, and disease status according to protocol-specified eligibility criteria
8. 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/Barrier 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.
Exclusion Criteria:
* Participants are excluded from the study if any of the following criteria apply:
1. History of Diagnosis of protocol-specified medical conditions
2. Spinal cord compression or brain metastasis prior to start of study intervention unless asymptomatic and stable
3. Persistent toxicities (CTCAE Grade ≥ 2), with the exception of alopecia and vitiligo, caused by previous anticancer therapy.
4. History of allogenic organ transplant or autoimmune or inflammatory disorders requiring use of immunosuppressive medications with some protocol specified conditions/exceptions
5. Any medical or surgical condition that would preclude adequate absorption of Ceralasertib
6. Inadequate cardiac function / status or other cardiovascular diseases
7. Participants with active infection requiring systemic antibiotics, antifungal or antiviral drugs
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
9. Protocol-specified prior/concomitant therapy exclusions
10. Protocol-specified prior/concurrent clinical study experience
11. Other Exclusions including but not limited to tobacco/nicotine and/or alcohol use, or drug/alcohol abuse history
12. Not currently pregnant, breast-feeding, or planning to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06754761
Study Brief:
Protocol Section:
NCT06754761