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NCT02588261 · ClinicalTrials.gov registry record · Phase 3
A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT02588261 is a Phase 3 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 530 participants.
The verdict
NCT02588261, a Phase 3 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.
Interventions
- DRUG Gefitinib
- DRUG Erlotinib
- DRUG naquotinib mesilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2016-02-11 |
| Est. Completion | 2017-12-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02588261
The ClinicalTrials.gov registry entry for NCT02588261 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gefitinib is the first listed.
NCT02588261 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02588261 about?
NCT02588261 is a clinical study titled "A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations". The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with...
What is the current status of trial NCT02588261?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2016-02-11. Estimated completion is 2017-12-21.
What interventions are being tested in trial NCT02588261?
The interventions under investigation include: Gefitinib (DRUG), Erlotinib (DRUG), naquotinib mesilate (DRUG).
Who is sponsoring clinical trial NCT02588261?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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