Status:
ACTIVE_NOT_RECRUITING
Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents
Lead Sponsor:
AstraZeneca
Conditions:
Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
PHASE2
Brief Summary
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 patient...
Detailed Description
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 patien...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT02264678
Start Date
October 31 2014
End Date
December 31 2025
Last Update
November 5 2025
Active Locations (28)
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1
Research Site
Duarte, California, United States, 91010
2
Research Site
Irvine, California, United States, 92618
3
Research Site
Los Angeles, California, United States, 90024
4
Research Site
Los Angeles, California, United States, 90089