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

Official record

Identifier

NCT02264678

Recruiting locations

countries

United StatesFranceSouth KoreaUnited Kingdom

Interventions studied

Administration of ceralasertibAdministration of ceralasertib in combination with olaparibAdministation of ceralasertib in combination with durvalumabAdministration of ceralasertib monotherapyAdministration of ceralasertib and olaparibAdministration of ceralasertib and durvalumabAdministration of ceralasertib in combination with AZD5305Administration of ceralasertib in combination with carboplatin

Lead sponsor

AstraZeneca

Target enrolment

358 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Active, not recruiting

First posted

Oct 15, 2014

Last updated on the registry

Jul 24, 2026

Age

18 Years – 130 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Principal 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 thrid 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

Principal 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

Indexed under

Gastric Cancer