Clinical Trial: NCT02264678
Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-07-24 |
Study Overview
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 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.
Official Title
Conditions
Intervention / 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
Other Study ID Numbers
- D5330C00004
- 2023-505006-41-00
- 2014-002233-66
- 2014
- 2023
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-07-24 |
Study Overview
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 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.
Official Title
Conditions
Intervention / 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
Other Study ID Numbers
- D5330C00004
- 2023-505006-41-00
- 2014-002233-66
- 2014
- 2023