NCT02264678Active, not recruitingPhase 1
Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents
A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 358 (actual)
- First submitted
- 30 Jul 2014
- Start date
- 31 Oct 2014
- Primary completion date
- 4 Mar 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer, Ovarian cancer
- NCT number
- NCT02264678
- EU CT number
- 2023-505006-41-00
- EudraCT number
- 2014-002233-66
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 358
- From 31 Oct 2014 to the primary completion date, 4 Mar 2025
- 22 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
- Safety and efficacy of ceralasertib, an ATR kinase inhibitor, combined with olaparib: dose escalation in advanced solid tumours and dose expansion in advanced breast cancer.Br J Cancer · 2026 · PMID 42816529
- Phase 1 study of ceralasertib, an ATR kinase inhibitor, in combination with durvalumab in patients with recurrent or metastatic NSCLC or HNSCC.Br J Cancer · 2026 · PMID 41917211
This page is information, not medical advice. Discuss any trial with your doctor.