Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib

Launched by ASTRAZENECA · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Ceralasertib, which is being tested for patients with certain types of cancer, including non-small cell lung cancer (NSCLC), ovarian cancer, and endometrial cancer. The trial has two parts: the first part will look at how the body absorbs, processes, and eliminates Ceralasertib when taken orally and through a small injection. The second part will further investigate how the body handles the medication. Participants will need to stay at the study site for a specific period to help researchers collect information about how the drug is processed in their bodies and to monitor their safety.

To be eligible, participants must be 18 years or older, have a documented diagnosis of one of the specified cancers, and be in good enough health to tolerate the study procedures. This means they should have a reasonable life expectancy, be able to swallow pills, and have regular bowel movements. Participants will be closely monitored during their stay and will also have a follow-up visit after completing the study to ensure their safety. After the trial, if the doctor believes it could help, participants might have the chance to continue receiving Ceralasertib.

Gender

ALL

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