Advanced Solid TumoursPhase 1NCT06929260
A Study to Evaluate the Effect of Ceralasertib on Drug X, Drug Y and Drug Z
A Phase 1 study testing Ceralasertib, Drug X and Drug Y in people with Advanced Solid Tumours, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The study aims to assess the effect of ceralasertib on the pharmacokinetics (PK) of Drug X, Drug Y and Drug Z in participants with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- Ceralasertib, Drug X and Drug Y
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 May 2025to 18 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented locally advanced or metastatic solid tumour(s) of non-small cell lung cancer, ovarian cancer, endometrial cancer, breast cancer or prostate cancer at Screening.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 with no deterioration over the 2 weeks prior to dosing.
- Ability to swallow and retain oral medication.
- Minimum life expectancy ≥ 12 weeks in the opinion of the Investigator.
- Adequate organ and marrow function during Screening.
- Body weight > 30 kg and no cancer-associated cachexia.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Diagnosis of ataxia telangiectasia (ATR).
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of the study intervention and of low potential risk for recurrence.
- Basal cell carcinoma of the skin.
- Curatively treated in situ cancer of the cervix.
- Ductal carcinoma in situ.
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- Curatively treated lymphomas (without bone marrow involvement).
- Squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy.
- Adequately treated carcinoma in situ without evidence of disease.
- History of leptomeningeal carcinomatosis.
- History of myelodysplastic syndromes (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation).
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention.
- Spinal cord compression or brain metastases for at least 4 weeks prior to start of study intervention unless asymptomatic and stable.
- Persistent toxicities, with the exception of alopecia and vitiligo, caused by previous anti-cancer therapy.
- Participants with any known predisposition to bleeding.
- Refractory nausea and vomiting, chronic gastrointestinal diseases associated with diarrhoea, or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of ceralasertib.
- Any of the following cardiac criteria or cardiovascular diseases -
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
- Any factors that increase the risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age.
- Participants at risk of brain perfusion problems.
- Participants with relative hypotension or uncontrolled hypertension requiring clinical intervention.
- Hypertensive heart disease with significant left ventricular hypertrophy or clinically significant valvular heart disease.
- History of atrial or ventricular arrhythmia requiring treatment.
- Transient ischaemic attack or stroke within 6 months prior to Screening.
- Any participant with active infection requiring systemic antibiotics, antifungal or antiviral drugs.
- Participants with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or active infection requiring systemic antibiotics, antifungal or antiviral drugs.
- Any prior treatment with an ATR inhibitor or checkpoint kinase inhibitor.
- Any concomitant treatment of central nervous system depressants, opioids, and centrally acting anti-hypertensive agents.
- Receipt of the last dose anti-cancer therapy within 4 weeks or 5 half-lives prior to the first dose of ceralasertib, whichever is shorter.
- Concomitant use of proton pump inhibitors, histamine H2 receptor antagonists, and other anti-acid agents.
- Palliative radiotherapy with a limited field of radiation within 2 weeks.
- Receiving or intend to receive any prescription or non-prescription drugs within 7 days or 5 half-lives before first dose of study intervention.
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in or history of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Drug X, Drug Y and Drug Z in Participants With Advanced Solid Tumours
The study aims to assess the effect of ceralasertib on the pharmacokinetics (PK) of Drug X, Drug Y and Drug Z in participants with advanced solid tumours.
Read the detailed description
This is an open-label, 3-period fixed-sequence study. The study will comprise of -
- Screening Visit (Visit 1)
- Period 1 (Visit 2)
- Period 2 (Visit 3)
- Period 3 (Visit 4)
- Follow-up Visit (Visit 5)
A wash-out period of no less than 48 hours in each period.
- Conditions
- Advanced Solid Tumours
- Being tested
- Ceralasertib, Drug X, Drug Y, Drug Z
- Keywords
- Pharmacokinetics, Drug-drug interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeralasertibDrug
Also called AZD6738
Participants will receive repeated dosing of ceralasertib from Day 1 to Day 7 until steady state.
Drug XDrug
Participants will receive a single dose of Drug X on Day 5 and Day 22.
Drug YDrug
Participants will receive a single dose of Drug Y on Day 7 and Day 28.
Drug ZDrug
Participants will receive a single dose of Drug Z on Day 7 and Day 28.
| Study group | Role | What they receive |
|---|---|---|
| Ceralasertib, Drug X, Drug Y and Drug Z | Experimental | Participants will receive ceralasertib twice daily (BD) from Day 1 to Day 7. Participants will also receive a single dose of Drug X on Day 5 and Day 22. Similarly, a single dose of Drug Y and Drug Z on Day 7 and Day 28. Receives: Drug: Ceralasertib; Drug: Drug X; Drug: Drug Y; Drug: Drug Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Measured: From Day 5 to Day 30
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Measured: From Day 5 to Day 30
Maximum observed concentration (Cmax)
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Measured: From Day 5 to Day 30
Plasma terminal elimination half-life (plasma t1/2λz)
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Measured: From Day 5 to Day 30
Terminal elimination rate constante (λz)
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Measured: From Day 5 to Day 30
Time to Reach Maximum Concentration Following Drug Administration (tmax)
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Measured: From Day 5 to Day 30
Secondary outcomes (2)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of ceralasertib.
Measured: From Screening to follow up visit, for up to 65 days
Trough concentrations of ceralasertib.
To assess ceralasertib steady state.
Measured: Day 4 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start21 May 2025
- Primary completion15 Oct 2025
- Study completion18 Dec 2025
Why it stopped: The study terminated because 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 Advanced Solid TumoursStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929260
- Sponsor's protocol ID
- D533BC00003
- Other IDs
- 2024-516611-24-00
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2025
- Last updated
- 24 Jul 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Drug X, Drug Y and Drug Z in Participants With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06929260
- Acronym / sponsor ID
- D533BC00003
- Conditions
- Advanced Solid Tumours
- Keywords
- Pharmacokinetics, Drug-drug interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study terminated because the clinical development programme for Ceralasertib has been discontinued.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 21 May 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 16 Apr 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.
The study aims to assess the effect of ceralasertib on the pharmacokinetics (PK) of Drug X, Drug Y and Drug Z in participants with advanced solid tumours.
Detailed description
This is an open-label, 3-period fixed-sequence study. The study will comprise of -
- Screening Visit (Visit 1)
- Period 1 (Visit 2)
- Period 2 (Visit 3)
- Period 3 (Visit 4)
- Follow-up Visit (Visit 5)
A wash-out period of no less than 48 hours in each period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceralasertib, Drug X, Drug Y and Drug Z | Experimental | Drug: Ceralasertib, Drug: Drug X, Drug: Drug Y, Drug: Drug ZParticipants will receive ceralasertib twice daily (BD) from Day 1 to Day 7. Participants will also receive a single dose of Drug X on Day 5 and Day 22. Similarly, a single dose of Drug Y and Drug Z on Day 7 and Day 28. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically documented locally advanced or metastatic solid tumour(s) of non-small cell lung cancer, ovarian cancer, endometrial cancer, breast cancer or prostate cancer at Screening.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 with no deterioration over the 2 weeks prior to dosing.
- Ability to swallow and retain oral medication.
- Minimum life expectancy ≥ 12 weeks in the opinion of the Investigator.
- Adequate organ and marrow function during Screening.
Key exclusion criteria (33 listed)
- Diagnosis of ataxia telangiectasia (ATR).
- History of another primary malignancy except for:
- History of leptomeningeal carcinomatosis.
- History of myelodysplastic syndromes (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation).
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention.
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 |
|---|---|---|
| CeralasertibAlso: AZD6738Participants will receive repeated dosing of ceralasertib from Day 1 to Day 7 until steady state. | Drug | Ceralasertib, Drug X, Drug Y and Drug Z |
| Drug XParticipants will receive a single dose of Drug X on Day 5 and Day 22. | Drug | Ceralasertib, Drug X, Drug Y and Drug Z |
| Drug YParticipants will receive a single dose of Drug Y on Day 7 and Day 28. | Drug | Ceralasertib, Drug X, Drug Y and Drug Z |
| Drug ZParticipants will receive a single dose of Drug Z on Day 7 and Day 28. | Drug | Ceralasertib, Drug X, Drug Y and Drug Z |
Primary outcome
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Time frame: From Day 5 to Day 30
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Time frame: From Day 5 to Day 30
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Maximum observed concentration (Cmax)
Time frame: From Day 5 to Day 30
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Plasma terminal elimination half-life (plasma t1/2λz)
Time frame: From Day 5 to Day 30
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Terminal elimination rate constante (λz)
Time frame: From Day 5 to Day 30
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
Time to Reach Maximum Concentration Following Drug Administration (tmax)
Time frame: From Day 5 to Day 30
To assess the effect of ceralasertib on the PK of Drug X, Drug Y and Drug Z.
2 secondary outcomes
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Screening to follow up visit, for up to 65 days
Trough concentrations of ceralasertib.
Time frame: Day 4 to Day 7
Results and safety
The study was stopped early (reason given: The study terminated because 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 24 Jul 2026.
- Redacted CSR 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 Ceralasertib, Drug X and Drug Y in people with Advanced Solid Tumours, 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 7 inclusion and 33 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 24 Jul 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: The study terminated because 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?
Area under plasma concentration-time curve from time 0 to infinity (AUCinf) (time frame: From Day 5 to Day 30). The study lists 6 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 24 Jul 2026.