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NCT02264678 · ClinicalTrials.gov registry record · Phase 1
Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents
A Phase 1 study of Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 1
- Development phase
- 357
- Enrollment target
- 20
- Study locations
NCT02264678: Active Phase 1 study of Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer, sponsored by AstraZeneca.
NCT02264678 is a Phase 1 study of Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 357 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (495% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02264678, a Phase 1 study of Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 357 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, DLT, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
Conditions Studied
Interventions
- 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
Study Locations (20)
Other
- Research Site - Bordeaux
- Research Site - Lyon
- Research Site - Saint-Herblain
- Research Site - Villejuif
- Research Site - Goyang-si
- Research Site - Seongnam-si
- Research Site - Seoul
- Research Site - Seoul
- Research Site - Seoul
- Research Site - Bristol
- Research Site - Cambridge
- Research Site - Coventry
California
- Research Site - Duarte
- Research Site - Irvine
- Research Site - Los Angeles
- Research Site - Los Angeles
- Research Site - Newport Beach
Massachusetts
- Research Site - Boston
New York
- Research Site - New York
Pennsylvania
- Research Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2014-10-31 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT02264678 still lists
NCT02264678 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (495% higher).
The record links to 1 condition, with Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Administration of ceralasertib is the first listed.
NCT02264678 names 20 study sites across 5 states, led by Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02264678 about?
NCT02264678 is a clinical study titled "Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents". 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 o...
What is the current status of trial NCT02264678?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 357 participants. The study started on 2014-10-31. Estimated completion is 2026-06-30.
What conditions does trial NCT02264678 study?
This clinical trial studies the following conditions: Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer.
What interventions are being tested in trial NCT02264678?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT02264678?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02264678 being conducted?
This trial has 20 study locations across California, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02264678's enrollment target sits among peer trials
357 95th of 2000 higher than 1,906 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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