NeoplasmPhase 1NCT06754761
Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib
A Phase 1 study testing [14C] AZD6738 and AZD6738 / ceralasertib in people with Neoplasm, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This is an open-label, two-part study in participants with solid tumours and will be conducted at multiple study sites. Participants will be assessed for study eligibility prior to admission to the study site. Participants may be enrolled in either Part A or Part B of the study or in both. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- [14C] AZD6738 and AZD6738 / ceralasertib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2025to 21 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age
- 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
- Sufficient ECOG performance status, life expectancy, and ability to swallow and retain oral medication
- Adequate organ and marrow function
Show all 12Show fewer
- Willingness and ability to comply with study and follow-up procedures.
- Able and willing to stay in hospital for specified residential periods following administration of Ceralasertib/[14C]-Ceralasertib
- Regular bowel movements
- Locally advanced or metastatic solid tumour, for which standard therapy does not exist or has proven to be ineffective or intolerable.
- 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
- 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.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- History of Diagnosis of protocol-specified medical conditions
- Spinal cord compression or brain metastasis prior to start of study intervention unless asymptomatic and stable
- Persistent toxicities (CTCAE Grade ≥ 2), with the exception of alopecia and vitiligo, caused by previous anticancer therapy.
- Any medical or surgical condition that would preclude adequate absorption of Ceralasertib
- Inadequate cardiac function / status or other cardiovascular diseases
Show all 12Show fewer
- Participants with active infection requiring systemic antibiotics, antifungal or antiviral drugs
- 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
- Protocol-specified prior/concomitant therapy exclusions
- Protocol-specified prior/concurrent clinical study experience
- Other Exclusions including but not limited to tobacco/nicotine and/or alcohol use, or drug/alcohol abuse history
- Not currently pregnant, breast-feeding, or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 Advanced Solid Tumours
This is an open-label, two-part study in participants with solid tumours and will be conducted at multiple study sites.
Participants will be assessed for study eligibility prior to admission to the study site.
Read more
Participants may be enrolled in either Part A or Part B of the study or in both.
Part 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.
Participants 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 if participants are taking part in both parts of the study.
Part B will assess the ADME of [14C]-Ceralasertib.
Participants 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.
Participants will return to the study site for a Follow-up Visit after the last dose of Ceralasertib which will include routine safety assessments.
After the completion of Parts A and/or B, and following the Follow-up Visit, participants may be allowed further access to Ceralasertib if in the opinion of the investigator they may derive clinical benefit.
- Conditions
- Neoplasm
- Being tested
- [14C] AZD6738, AZD6738 / ceralasertib
- Keywords
- advanced solid tumours, hADME, bioavailability, AZD6738, ceralasertib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] AZD6738Drug
radiolabeled AZD6738 / ceralasertib
AZD6738 / ceralasertibDrug
Ceralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase ATR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: [14C] AZD6738; Drug: AZD6738 / ceralasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate absolute bioavailability Ceralasertib and PK of Ceralasertib and [14C]-Ceralasertib after administration of oral dose of Ceralasertib and IV [14C]-Ceralasertib (Part A)
Absolute bioavailability (F) of Ceralasertib and PK parameters and recovery in urine and faeces
Measured: Through end of Part A, approximately 5 weeks including screening period
To determine the rates and major excretory routes of Ceralasertib and its metabolites after IV dose of [14C]-Ceralasertib (Part A) and a oral dose of [14C]-Ceralasertib (Part B)
[14C]-Ceralasertib (Part A) or total radioactivity (Part B) recovery in urine and faeces
Measured: Through end of Part B, approximately 10 weeks including screening period
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
AUCinf
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
AUClast
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Cmax
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
tmax
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
t1/2(lambda)z
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Ratio of AUCinf of plasma Ceralasertib relative to AUCinf of plasma total radioactivity
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Ratio of AUCinf of whole blood total radioactivity relative to AUCinf of plasma total radioactivity
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine Ae
Urine - Ae
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine CumAe
Urine - CumAe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine Fe
Urine - Fe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine CumFe
Urine - CumFe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces Ae
Faeces - Ae
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces CumAe
Faeces - CumAe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces Fe
Faeces - Fe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces CumFe
Faeces - CumFe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) Ae
Total (Urine + Faeces) Ae
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) CumAe
Total (Urine + Faeces) CumAe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) Fe
Total (Urine + Faeces) Fe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) CumFe
Total (Urine + Faeces) CumFe
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
Secondary outcomes (2)
To provide biologic samples for metabolic profiling and identification after oral dose of [14C]-Ceralasertib (Part B)
Quantification and identification of major metabolites of Ceralasertib in plasma and excreta (will be reported separately)
Measured: Through end of the part B, approximately 10 weeks (Including screening period)
To assess the safety of Ceralasertib in participants with advanced solid tumours (Parts A and B)
Incidence and severity of AEs Incidence of laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results 12-lead ECG parameters Vital signs measurements Physical examinations
Measured: Through study completion, approximately 9 - 11 weeks, with screening included
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start22 Sep 2025
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Why it stopped: A decision, based solely on business strategy, was taken to terminate study D533BC00002 on 22 December 2025, as the clinical development programme for ceralasertib has been discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754761
- Sponsor's protocol ID
- D533BC00002
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06754761
- Acronym / sponsor ID
- D533BC00002
- Conditions
- Neoplasm
- Keywords
- advanced solid tumours, hADME, bioavailability, AZD6738, ceralasertib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A decision, based solely on business strategy, was taken to terminate study D533BC00002 on 22 December 2025, as the clinical development programme for ceralasertib has been discontinued.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, two-part study in participants with solid tumours and will be conducted at multiple study sites.
Participants will be assessed for study eligibility prior to admission to the study site.
Participants may be enrolled in either Part A or Part B of the study or in both.
Part 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.
Participants 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 if participants are taking part in both parts of the study.
Part B will assess the ADME of [14C]-Ceralasertib.
Participants 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.
Participants will return to the study site for a Follow-up Visit after the last dose of Ceralasertib which will include routine safety assessments.
After the completion of Parts A and/or B, and following the Follow-up Visit, participants may be allowed further access to Ceralasertib if in the opinion of the investigator they may derive clinical benefit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Treatment Arm - AZD6738 | Experimental | Drug: [14C] AZD6738, Drug: AZD6738 / ceralasertibPart A - oral dose of Ceralasertib and a radiolabelled IV microdose of [14C]-Ceralasertib Part B - oral dose of [14C]-Ceralasertib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age
- 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
- Sufficient ECOG performance status, life expectancy, and ability to swallow and retain oral medication
Key exclusion criteria (12 listed)
- Participants are excluded from the study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C] AZD6738radiolabeled AZD6738 / ceralasertib | Drug | Primary Treatment Arm - AZD6738 |
| AZD6738 / ceralasertibCeralasertib (AZD6738) is a potent, selective inhibitor of the serine/threonine-specific protein kinase ATR | Drug | Primary Treatment Arm - AZD6738 |
Primary outcome
To evaluate absolute bioavailability Ceralasertib and PK of Ceralasertib and [14C]-Ceralasertib after administration of oral dose of Ceralasertib and IV [14C]-Ceralasertib (Part A)
Time frame: Through end of Part A, approximately 5 weeks including screening period
Absolute bioavailability (F) of Ceralasertib and PK parameters and recovery in urine and faeces
To determine the rates and major excretory routes of Ceralasertib and its metabolites after IV dose of [14C]-Ceralasertib (Part A) and a oral dose of [14C]-Ceralasertib (Part B)
Time frame: Through end of Part B, approximately 10 weeks including screening period
[14C]-Ceralasertib (Part A) or total radioactivity (Part B) recovery in urine and faeces
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
AUCinf
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
AUClast
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Cmax
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
tmax
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
t1/2(lambda)z
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Ratio of AUCinf of plasma Ceralasertib relative to AUCinf of plasma total radioactivity
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Ratio of AUCinf of whole blood total radioactivity relative to AUCinf of plasma total radioactivity
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine Ae
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Urine - Ae
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine CumAe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Urine - CumAe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine Fe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Urine - Fe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Urine CumFe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Urine - CumFe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces Ae
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Faeces - Ae
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces CumAe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Faeces - CumAe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces Fe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Faeces - Fe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Faeces CumFe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Faeces - CumFe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) Ae
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Total (Urine + Faeces) Ae
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) CumAe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Total (Urine + Faeces) CumAe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) Fe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Total (Urine + Faeces) Fe
To characterise the PK of Ceralasertib and total radioactivity following oral dose of [14C]-Ceralasertib including the extent of distribution into blood cells (Part B) - Total (Urine+Faeces) CumFe
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
Total (Urine + Faeces) CumFe
2 secondary outcomes
To provide biologic samples for metabolic profiling and identification after oral dose of [14C]-Ceralasertib (Part B)
Time frame: Through end of the part B, approximately 10 weeks (Including screening period)
To assess the safety of Ceralasertib in participants with advanced solid tumours (Parts A and B)
Time frame: Through study completion, approximately 9 - 11 weeks, with screening included
Results and safety
The study was stopped early (reason given: A decision, based solely on business strategy, was taken to terminate study D533BC00002 on 22 December 2025, as the clinical development programme for ceralasertib has been discontinued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- d533bc00002-synoptic-form-study-synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] AZD6738 and AZD6738 / ceralasertib in people with Neoplasm, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: A decision, based solely on business strategy, was taken to terminate study D533BC00002 on 22 December 2025, as the clinical development programme for ceralasertib has been discontinued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate absolute bioavailability Ceralasertib and PK of Ceralasertib and [14C]-Ceralasertib after administration of oral dose of Ceralasertib and IV [14C]-Ceralasertib (Part A) (time frame: Through end of Part A, approximately 5 weeks including screening period). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.