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NCT02326584 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT02326584 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 116 participants.
The verdict
NCT02326584, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
Interventions
- DRUG Daunorubicin
- DRUG Standard dose cytarabine for induction
- DRUG SGN-CD33A
- DRUG High dose cytarabine for consolidation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-04-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02326584
The ClinicalTrials.gov registry entry for NCT02326584 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, which has 84 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Daunorubicin is the first listed.
NCT02326584 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02326584 about?
NCT02326584 is a clinical study titled "A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML". This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in...
What is the current status of trial NCT02326584?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2014-12. Estimated completion is 2018-04-10.
What interventions are being tested in trial NCT02326584?
The interventions under investigation include: Daunorubicin (DRUG), Standard dose cytarabine for induction (DRUG), SGN-CD33A (DRUG), High dose cytarabine for consolidation (DRUG).
Who is sponsoring clinical trial NCT02326584?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
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