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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 72 participants.
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.
Interventions
- DRUG AZD2811
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-10-28 |
| Est. Completion | 2020-04-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02579226
The ClinicalTrials.gov registry entry for NCT02579226 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AZD2811 is the first listed.
NCT02579226 reports 0 study locations.
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.
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