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NCT01902329 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of SGN-CD33A in AML Patients
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 195
- Enrollment target
NCT01902329 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 195 participants.
The verdict
NCT01902329, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 195 participants
- Enrollment target
Study Summary
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD 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-leukemia activity of SGN-CD33A will be assessed.
Interventions
- DRUG SGN-CD33A
- DRUG HMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-12-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01902329
The ClinicalTrials.gov registry entry for NCT01902329 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 195 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 2 interventions - of which SGN-CD33A is the first listed.
NCT01902329 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01902329 about?
NCT01902329 is a clinical study titled "A Safety Study of SGN-CD33A in AML Patients". This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable s...
What is the current status of trial NCT01902329?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 195 participants. The study started on 2013-07. Estimated completion is 2017-12-08.
What interventions are being tested in trial NCT01902329?
The interventions under investigation include: SGN-CD33A (DRUG), HMA (DRUG).
Who is sponsoring clinical trial NCT01902329?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
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