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NCT02579226 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Safety, Tolerability, and PK of AZD2811 in Patients With Advanced Solid Tumors.
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT02579226: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02579226 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02579226, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811 at increasing doses in patients with advanced solid tumours and for whom no standard of care exists. The study will be conducted in two parts, a dose-escalation phase (Part A) and a dose expansion phase (Part B). During Part A, the dose-escalation phase, patient enrolment will proceed according to a 3+3 design where the maximum tolerated dose (MTD) or the recommended Phase II dose (RP2D) could be identified. The study will also characterize the pharmacokinetic (PK) profile of AZD2811 and will explore the potential biological activity by assessing anti-tumour activity in patients. Part B will further explore PK parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD2811 RP2D as monotherapy (Group 1) in patients with relapsed/refractory SCLC.
Primary Outcome
Maximum Tolerated Dose (MTD) will be determined in Part A of the study by assessing the incidence of Dose Limiting Toxicities (DLTs), adverse events, and abnormal laboratory results. DLT is defined as: 1. Grade 4 neutropenia for \> 7 days, or febrile neutropenia. 2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding. 3. Concurrent Grade ≥3 total bilirubin, ALT or AST or alkaline phosphatase lasting \> 48 hours, or any change in liver function test results consistent with Hy's
Interventions
- DRUG AZD2811
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-10-28 |
| Est. Completion | 2020-04-03 |
| Phase | Phase 1 |
What the finished NCT02579226 record still lists
NCT02579226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 1 intervention - of which AZD2811 is the first listed.
NCT02579226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02579226 about?
NCT02579226 is a clinical study titled "A Phase I Study of Safety, Tolerability, and PK of AZD2811 in Patients With Advanced Solid Tumors.". This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811 at increasing doses in patients with advanced solid tumours and for whom no standard of care exists. The study will be conducted in two parts, a dose-escalation phase (Part A) and a dose expansion phase (Part...
What is the current status of trial NCT02579226?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2015-10-28. Estimated completion is 2020-04-03.
What interventions are being tested in trial NCT02579226?
The interventions under investigation include: AZD2811 (DRUG).
Who is sponsoring clinical trial NCT02579226?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02579226's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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