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Be Part of Research - Trial Details - Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents
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Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

Not Recruiting

Open to: ALL

Age: 18.0 - 130.0

Cambridge Sutton London Oxford London Coventry London London Withington Bristol Manchester

Medical Conditions

Hereditary Breast and Ovarian Cancer Syndrome

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2014 Mar 2025

Publications

"Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561."; "34904813"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Module 2 Part A1;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Module 2 Part A2;Module 2 Part B1;Module 2 Part B2;Module 2 Part B3;Module 2 Part B4;Module 2 Part B5;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Module 3 Part A;Module 3 Part B;

Intervention Type : DRUG
Intervention Description : 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

Intervention Arm Group : Module 4 (FE/QT);

Intervention Type : DRUG
Intervention Description : Module 4 Part B Cohort 1:

After completion of Part A (C0), the patient may transition to Part B and be allocated to receive ceralasertib in combination with olaparib as decided by the investigator.

Intervention Arm Group : Module 4 (FE/QT);

Intervention Type : DRUG
Intervention Description : Module 4 Part B Cohort 2:

After completion of Part A (C0), the patient may transition to Part B and be allocated to receive ceralasertib in combination with durvalumab as decided by the investigator.

Intervention Arm Group : Module 4 (FE/QT);

Intervention Type : DRUG
Intervention Description : 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).

Intervention Arm Group : Module 5 Part A;Module 5 Part B;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Module 1 Part A;Module 1 Part B;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    Cambridge
    CB2 0QQ
  • Research Site
    Sutton
    SM2 5PT
  • Research Site
    London
    W1G 6AD
  • Research Site
    Oxford
    OX3 7LE
  • Research Site
    London
    SW3 6JJ
  • Research Site
    Coventry
    CV2 2DX
  • Research Site
    London
    W12 0HS
  • Research Site
    London
    W1T 7HA
  • Research Site
    Withington
    M20 4BX
  • Research Site
    Bristol
    BS2 8ED
  • Research Site
    Manchester
    M20 4GJ


The study is sponsored by AstraZeneca



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Read full details for Trial ID: NCT02264678
Last updated 17 March 2025

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