A Study to Evaluate the Effect of Ceralasertib on Drug X, Drug Y and Drug Z

NCT06929260 | Terminated Phase 1

• 2 other identifiers: D533BC000032024-516611-24-00
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumours

Keywords

Pharmacokinetics; Drug-drug interactions

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  From Day 5 to Day 30

Secondary Outcomes (2)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  From Screening to follow up visit, for up to 65 days

• Trough concentrations of ceralasertib.

  Day 4 to Day 7

Study Arms (1)

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.

Drug: Ceralasertib; Drug: Drug X; Drug: Drug Y; Drug: Drug Z

Interventions

Ceralasertib DRUG

Participants will receive repeated dosing of ceralasertib from Day 1 to Day 7 until steady state.

Also known as: AZD6738

Ceralasertib, Drug X, Drug Y and Drug Z

Drug X DRUG

Participants will receive a single dose of Drug X on Day 5 and Day 22.

Ceralasertib, Drug X, Drug Y and Drug Z

Drug Y DRUG

Participants will receive a single dose of Drug Y on Day 7 and Day 28.

Ceralasertib, Drug X, Drug Y and Drug Z

Drug Z DRUG

Participants will receive a single dose of Drug Z on Day 7 and Day 28.

Ceralasertib, Drug X, Drug Y and Drug Z

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Interventions

ceralasertib; factor IX, factor VII, factor X, prothrombin drug combination; drug XX Z

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 16, 2025
• Study Start: May 21, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 18, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST /Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (1)