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Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

PHASE1PHASE2RECRUITING

This is a modular, phase I/ phase 1 b, open-label, multicentre study of ceralasertib administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of ceralasertib with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is ceralasertib with carboplatin.

The second combination to be investigated is ceralasertib with Olaparib. The third combination to be investigated is ceralasertib with durvalumab. The fourth module will investigate the effect of food on ceralasertib absorption and the effect of ceralasertib on ECG parameter.

The fifth module to be investigated is ceralasertib with AZD5305.

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Study details:

This is a modular, phase I, two part, open-label, multicentre study of ceralasertib, administered orally, in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced/metastatic solid malignancies. The study design allows an escalation of the dose of ceralasertib in combination with the standard dose and schedule of either cytotoxic chemotherapies and/or novel anti-cancer agents, with intensive safety monitoring to ensure the safety of the patients. There are two parts to each combination module of this study; part A, dose escalation and an optional part B, cohort expansions in particular patient groups.

The initial combination module will be with Carboplatin (module 1). The second combination will be with Olaparib (module 2). The third combination will be with durvalumab (module 3), the fourth combination will be AZD5305 (Module 5).

The option to start further combination modules will be the decision of the Safety Review Committee (SRC), based on emerging preclinical data and, safety and tolerability information from the initial combination. Combinations of ceralasertib with novel anti-cancer agents may also be explored. Once a minimally biologically active dose of ceralasertib, for that combination module, has been identified from part A of that module, the SRC may decide to commence part B if deemed to be necessary.

This may include cohort expansions of specific patient groups to explore preliminary anti-tumour activity or the effect of food or particular drug combinations on drug pharmacokinetics. The fourth module will investigate the effect of food on ceralasertib absorption and whether ceralasertib has an effect on QT.

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Eligibility criteria

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Inclusion criteria

Aged at least 18

The presence of a solid malignant tumour that is not considered appropriate for further standard treatment

Module 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan

Module 2 Part B All (except B5): No previous treatment with PARP inhibitor.

Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours

Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours

Module 2 Part B3 Study expansion: Second or third line HER2 negative breast cancer

Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC)

Module 2 Part B5 Study expansion: BRCAm or RAD51C/Dm or PALB2m or HRD positive status ovarian cancer patient who are Platinum Sensitive Relapsed and have previously progressed on a licensed PARPi

Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma

Module 4: any advanced solid tumours except gastric, gastro-oesophageal, oesophageal or colorectal cancer with a small bowel resection

Module 4: Ability to comply with an overnight fast of at least 10 hours prior to dosing and 4 hours after dosing as mandated, and ability to eat a high fat meal as mandated

Module 5 All: Ovarian fallopian tube or primary peritonial cancer, previous treatment with PARP inhibitor, platinum-sensitive relapsed ovarian cancer

Module 5 Part B: known or suspected BRCA mutation, PALB2 mutation, RAD51C/D mutation or HRD positive status

Exclusion criteria

A diagnosis of ataxia telangiectasia

Prior exposure to an ATR inhibitor

Bad reaction to ceralasertib

Module 2: Contra-indicated for treatment with olaparib

Module 3: Contra-indicated for treatment with durvalumab

Module 4: Mean resting corrected QT interval (QTc) >470 msec or history of familial long QT syndrome.

Module 4: Patients with type I or type II diabetes

Module 5: Known hypersensitivity to PARP including AZD5305

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2014-10-31

Primary completion: 2025-03-18

Study completion finish: 2025-03-18

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT02264678

Intervention or treatment

DRUG: Administration of ceralasertib

DRUG: Administration of ceralasertib in combination with olaparib

DRUG: Administation of ceralasertib in combination with durvalumab

DRUG: Administration of ceralasertib monotherapy

DRUG: Administration of ceralasertib and olaparib

DRUG: Administration of ceralasertib and durvalumab

DRUG: Administration of ceralasertib in combination with AZD5305

DRUG: Administration of ceralasertib in combination with carboplatin

Conditions

• Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer

Image related to Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer

Condition: Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer
DRUG: Administration of ceralasertib and other drugs
Nedlands, Not Specified, Australia
Sponsor: AstraZeneca

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Research Site
Nedlands, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Module 2 Part A1 Module 2 Part A1: ascending doses of ceralasertib will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.	DRUG: Administration of ceralasertib An oral formulation of ceralasertib will be used. In Module 2 Part A1, patients will receive a single dose of ceralasertib on Day 1, followed by 4 to 6 days washout, before multiple dosing.
EXPERIMENTAL: Module 2 Part A2 Module 2 Part A2: ascending doses of ceralasertib will be administered in combination with olaparib to patients to define the dose, frequency and schedule of ceralasertib and olaparib to take into Module 2 Part B.	DRUG: Administration of ceralasertib in combination with olaparib An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
EXPERIMENTAL: Module 2 Part B1 Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.	DRUG: Administration of ceralasertib in combination with olaparib An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
EXPERIMENTAL: Module 2 Part B2 Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.	DRUG: Administration of ceralasertib in combination with olaparib An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
EXPERIMENTAL: Module 2 Part B3 Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.	DRUG: Administration of ceralasertib in combination with olaparib An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
EXPERIMENTAL: Module 2 Part B4 Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive ceralasertib with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.	DRUG: Administration of ceralasertib in combination with olaparib An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
EXPERIMENTAL: Module 3 Part A Module 3 Part A: cohort escalation of ceralasertib in combination with durvalumab in HNSCC or NSCLC patients to define the dose, frequency and schedule of ceralasertib and durvalumab to take into Module 3 Part B. Additionally, Module 3 Part A will include a serial tumour biopsy cohort to evaluate the Proof of Mechanism of ceralasertib in HNSCC and NSCLC patients.	DRUG: Administation of ceralasertib in combination with durvalumab An oral formulation of ceralasertib will be used. Durvalumab is given via IV infusion. In Module 3 Part A, patients will receive an initial single dose of ceralasertib on Day 1, followed by multiple dosing in combination with durvalumab. In Module 3 Serial Tumour Biopsy Extension and Part B expansion cohorts, patients will receive ceralasertib at the dose, frequency and schedule recommended from Module 3 Part A, in combination with durvalumab.
EXPERIMENTAL: Module 3 Part B Module 3 Part B: cohort expansions of ceralasertib in combination with durvalumab in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.	DRUG: Administation of ceralasertib in combination with durvalumab An oral formulation of ceralasertib will be used. Durvalumab is given via IV infusion. In Module 3 Part A, patients will receive an initial single dose of ceralasertib on Day 1, followed by multiple dosing in combination with durvalumab. In Module 3 Serial Tumour Biopsy Extension and Part B expansion cohorts, patients will receive ceralasertib at the dose, frequency and schedule recommended from Module 3 Part A, in combination with durvalumab.
EXPERIMENTAL: Module 2 Part B5 Patients with BRCA mutant or RAD51C/D mutant (either germline or somatic) or HRD-positive status epithelial ovarian, fallopian tube, or primary peritoneal cancer according to local testing. Patients must be platinum sensitive and previously progressed on a licensed PARPi. The cohort will be split into 2 groups: Cohort 1 - without intervening chemotherapy following progression on a PARPi, Cohort 2 - with intervening chemotherapy following progression on a PARPi. Patients will receive ceralasertib and olaparib, at the RP2D dose, frequency and schedule established from Module 2 Part A2.	DRUG: Administration of ceralasertib in combination with olaparib An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
EXPERIMENTAL: Module 4 (FE/QT) Ceralasertib monotherapy will be administered on a number of days during Cycle 0 to assess the effect of food on ceralasertib absorption and effect of ceralasertib on ECG parameters under various conditions (fasted, fed, steady state). From C1 onwards, patients who participated in C0 will be allocated to either ceralasertib in combination with olaparib or durvalumab, or ceralasertib monotherapy and assessed for safety.	DRUG: Administration of ceralasertib monotherapy Module 4 Part A and Module 4 Part B Cohort 3: During C0, patients will receive ceralasertib monotherapy orally once a day on 3 non-consecutive days and ceralasertib twice a day on 5 consecutive days. After the patients have completed C0 (Part A) they may transition to Module 4 Part B cohort 3 where they will continue to receive ceralasertib monotherapy
EXPERIMENTAL: Module 5 Part A Module 5 Part A: ascending doses of ceralasertib will be administered in combination with AZD5305 to patients to define the MTD, RP2D. In case this first dose level is not tolerated, alternative schedules will be evaluated.	DRUG: Administration of ceralasertib in combination with AZD5305 An oral formulations of ceralasertib and AZD5305 will be used. In Module 5 Part A, patients will receive a single dose of ceralasertib on cycle 0 Day 1 as per dose level cohort. In Module 5 Part B, patients will receive ceralasertib and AZD5305: C1 onwards (as per dose level cohort allocated).
EXPERIMENTAL: Module 5 Part B Module 5 Part B: cohort expansions of ceralasertib in combination with AZD5305 in ovarian patients at dose, frequency and schedule from Module 5 Part A.	DRUG: Administration of ceralasertib in combination with AZD5305 An oral formulations of ceralasertib and AZD5305 will be used. In Module 5 Part A, patients will receive a single dose of ceralasertib on cycle 0 Day 1 as per dose level cohort. In Module 5 Part B, patients will receive ceralasertib and AZD5305: C1 onwards (as per dose level cohort allocated).
EXPERIMENTAL: Module 1 Part A Module 1 Part A: ascending doses of ceralasertib in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).	DRUG: Administration of ceralasertib in combination with carboplatin An oral formulation of ceralasertib will be used. In Module 1 Part A, patients will receive a single dose of ceralasertib on Day 1, followed by multiple dosing in combination with carboplatin. A maximum of 6 cycles (21 days per cycle) of treatment will be given. In Module 1 Part B, patients will receive ceralasertib and carboplatin at the dose, frequency and schedule recommended from Module 1 Part A.
EXPERIMENTAL: Module 1 Part B Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive ceralasertib and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.	DRUG: Administration of ceralasertib in combination with carboplatin An oral formulation of ceralasertib will be used. In Module 1 Part A, patients will receive a single dose of ceralasertib on Day 1, followed by multiple dosing in combination with carboplatin. A maximum of 6 cycles (21 days per cycle) of treatment will be given. In Module 1 Part B, patients will receive ceralasertib and carboplatin at the dose, frequency and schedule recommended from Module 1 Part A.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
The number of subjects with adverse events/serious adverse events	Number of patients with adverse events and with serious adverse events including abnormal clinical observations, DLT, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.	From baseline until 28 days after discontinuation of study treatment for Module 1, 2 and 5 or until 90 days after discontinuation of study treatment for Module 3 and 4
Module 4 only: Effect of food on ceralasertib absorption by Intensive PK assessments after a single oral dose of ceralasertib (Part A)	Intensive PK sampling at defined timepoints to measure Geometric mean and 90% CI for the ratio of fed: fasted in area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t), area under the plasma concentration time curve from zero to infinity (AUC)	From 0h to 24h on Day 2 and Day15 in Cycle 0 (Part A) - Cycle 0 is 15 days
Module 4 only: Effect of ceralasertib on ECG parameters (HR, PR, QRS and QTcF) by ECG recordings	Change from baseline HR, PR, QRS and QTcF (ΔHR, ΔPR, ΔQRS and ΔQTcF) Categorical outliers for QTcF, HR, PR, and QRS Frequency of treatment emergent T and U wave abnormalities If a substantial HR effect is observed (i.e., the absolute value of the largest least squares \[LS\] mean ΔHR is greater than 10bpm in the by-time point analysis), other correction methods such as individualised and optimised individualised HR corrected QT interval (QTcI) will be explored and compared. The method that removes the HR dependence of the QT interval most efficiently will be chosen as the primary correction method.	From 0h to 24h on Day 2, Day 8 and Day15 in Cycle 0 (Part A) - Cycle 0 is 15 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Maximum Observed Plasma Concentration (Cmax) of ceralasertib	Blood samples will be collected to assess plasma concentration of ceralasertib at a series of time points to derive Cmax.	At predefined intervals throughout the ceralasertib treatment period (approximately 8 weeks for Module 1 and 16 weeks + IP disc. for Module 2+3)
Time to observed Cmax (Tmax) for ceralasertib	Blood samples will be collected to assess plasma concentration of ceralasertib at a series of time points to derive Tmax.	At predefined intervals throughout the ceralasertib treatment period (approximately 8 weeks for Module 1 and 16 weeks + IP disc. for Module 2+3)
Area under the plasma concentration-time curve (AUC) for ceralasertib	Blood samples will be collected to assess plasma concentration of ceralasertib at a series of time points to derive AUC.	At predefined intervals throughout the ceralasertib treatment period (approximately 8 weeks for Module 1 and 16 weeks + IP disc. for Module 2+3)
Maximum Observed Plasma Concentration (Cmax) of Carboplatin	Blood samples will be collected to assess plasma concentration of Carboplatin at a series of time points to derive Cmax.	At predefined intervals throughout the Carboplatin treatment period (approximately 4 weeks for Module 1)
Time to observed Cmax (Tmax) for Carboplatin	Blood samples will be collected to assess plasma concentration of Carboplatin at a series of time points to derive Tmax.	At predefined intervals throughout the Carboplatin treatment period (approximately 4 weeks for Module 1)
Area under the plasma concentration-time curve (AUC) for Carboplatin	Blood samples will be collected to assess plasma concentration of Carboplatin at a series of time points to derive AUC.	At predefined intervals throughout the Carboplatin treatment period (approximately 4 weeks for Module 1)
Maximum Observed Plasma Concentration (Cmax) of Olaparib	Blood samples will be collected to assess plasma concentration of Olaparib at a series of time points to derive Cmax.	At predefined intervals throughout the Olaparib treatment period (approximately 12 weeks for Module 2)
Time to observed Cmax (Tmax) for Olaparib	Blood samples will be collected to assess plasma concentration of Olaparib at a series of time points to derive Tmax.	At predefined intervals throughout the Olaparib treatment period (approximately 12 weeks for Module 2)
Area under the plasma concentration-time curve (AUC) for Olaparib	Blood samples will be collected to assess plasma concentration of Olaparib at a series of time points to derive AUC.	At predefined intervals throughout the Olaparib treatment period (approximately 12 weeks for Module 2)
Maximum Observed Plasma Concentration (Cmax) of durvalumab	Blood samples will be collected to assess plasma concentration of durvalumab at a series of time points to derive Cmax.	At predefined intervals throughout the durvalumab treatment period (approximately 28 weeks + 90days post IP disc. for Module 3)
Time to observed Cmax (Tmax) for durvalumab	Blood samples will be collected to assess plasma concentration of durvalumab at a series of time points to derive Tmax.	At predefined intervals throughout the durvalumab treatment period (approximately 28 weeks + 90days post IP disc. for Module 3)
Area under the plasma concentration-time curve (AUC) for durvalumab	Blood samples will be collected to assess plasma concentration of durvalumab at a series of time points to derive AUC.	At predefined intervals throughout the durvalumab treatment period (approximately 28 weeks + 90days post IP disc. for Module 3)
Assessment of pharmacodynamic biomarker changes	Evaluation of ceralasertib activity in the tumour by assessment of pharmacodynamic biomarker changes which may include, but are not limited to functional ATR inhibition, ctDNA and CTCs.	Biopsies of tumour at baseline and last day of dosing
Best objective response	Best objective response will be determined for each patient based on the best response recorded from start of study treatment to end of treatment, including any assessments for confirmation after the end of treatment using RECIST 1.1.	From first dose to confirmed progressive disease (approximately 1 year)
Objective response rate	Objective response rate is defined as the percentage of patients who have at least one response of CR or PR prior to any evidence of progression (as defined by RECIST 1.1) that is confirmed at least 4 weeks later.	From first dose to confirmed progressive disease (approximately 1 year)
Percentage change in tumour size	Percentage change in tumour size will be determined for patients with measurable disease at baseline and is derived at each visit by the percentage change from baseline in the sum of the diameters of TLs. The best percentage change in tumour size will be the patient's value representing the largest decrease (or smallest increase) from baseline in tumour size using RECIST 1.1.	From first dose to confirmed progressive disease (approximately 1 year)
Durable response rate	Duration of response will be defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint using RECIST 1.1.	From first documented response to confirmed progressive disease (approximately 1 year)
Progression free survival	Progression free survival (PFS) is defined as the time from start of treatment (first dose of ceralasertib) until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from therapy or receives another anti-cancer therapy prior to progression using RECIST 1.1.	From first dose to confirmed progressive disease (approximately 1 year)
Survival assessment /status	Module 2 only. To be obtained for all patients who received ceralasertib and olaparib in part A2, B1, B2, B3, B4 and B5.	From first dose to confirmed progressive disease (approximately 1 year)
Module 4: Safety and tolerability in terms of AE and SAE as recorded in safety measures	Safety measures: AEs assessments (CTCAE grading)	From baseline until 28 days after discontinuation of study treatment for Module 4 Part B cohort 1 and cohort 3, or until 90 days after discontinuation of study treatment for Module 4 Part B cohort 2
Module 4 only: Effect of food on ceralasertib absorption by Cmax in a fasted and fed state (Part A)	Intensive PK sampling at defined timepoints to measure geometric mean and 90% CI for the ratio of fed: fasted in Cmax - Maximum plasma concentration (Cmax)	Part A (Cycle 0 Day 2/Day 8/Day 15) - each cycle is of 15 days
Module 4 only: Effect of food on ceralasertib absorption by Tmax in a fasted and fed state (Part A)	Intensive PK sampling at defined timepoints to measure geometric mean and 90% CI for the ratio of fed: fasted in Tmax - time to reach maximum plasma concentration (Tmax)	Part A (Cycle 0 Day 2/Day 8/Day 15) - each cycle is of 15 days
Module 4 only: Effect of food on ceralasertib absorption by clearance in a fasted and fed state (Part A)	Intensive PK sampling at defined timepoints to measure geometric mean and 90% CI for the ratio of fed: fasted in apparent clearance following oral administration (CL/F)	Part A (Cycle 0 Day 2/Day 8/Day 15) - each cycle is of 15 days
Module 4 only: Effect of food on ceralasertib absorption by apparent volume of distribution in a fasted and fed state (Part A)	Intensive PK sampling at defined timepoints to measure geometric mean and 90% CI for the ratio of fed: fasted in apparent volume of distribution (Vz/F)	Part A (Cycle 0 Day 2/Day 8/Day 15) - each cycle is of 15 days
Module 4 only: Effect of food on ceralasertib absorption by terminal half-life and terminal rate constant in a fasted and fed state (Part A)	Intensive PK sampling at defined timepoints to measure geometric mean and 90% CI for the ratio of fed: fasted in terminal rate constant (λz), and terminal half-life (t1/2)	Part A (Cycle 0 Day 2/Day 8/Day 15) - each cycle is of 15 days
Module 4: The number of subjects with adverse events/serious adverse events	Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal vital signs, and abnormal laboratory assessments that changed from baseline	From baseline until 28 days after discontinuation of study treatment for Module 4 Part B cohort 1 and cohort 3, or until 90 days after discontinuation of study treatment for Module 4 Part B cohort 2
Module 5 only: Maximum Observed Plasma Concentration (Cmax) of AZD5305	Blood samples will be collected to assess plasma concentration of AZD5305 at a series of time points to derive Cmax.	At predefined intervals throughout AZD5305 treatment period (approximately 8 weeks + IP disc)
Module 5 only: Time to observed Cmax (Tmax) for AZD5305	Blood samples will be collected to assess plasma concentration of AZD5305 at a series of time points to derive Tmax.	At predefined intervals throughout AZD5305 treatment period (approximately 8 weeks + IP disc)
Module 5 only: Area under the plasma concentration-time curve (AUC) for AZD5305	Blood samples will be collected to assess plasma concentration of AZD5305 at a series of time points to derive AUC.	At predefined intervals throughout AZD5305 treatment period (approximately 8 weeks + IP disc)

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References

Clinical Trials Gov: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents