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NCT02472145 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 326
- Enrollment target
NCT02472145 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 326 participants.
The verdict
NCT02472145, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 326 participants
- Enrollment target
Study Summary
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
Interventions
- DRUG Decitabine 20 mg/m^2
- DRUG Talacotuzumab 9 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2015-08-04 |
| Est. Completion | 2018-01-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02472145
The ClinicalTrials.gov registry entry for NCT02472145 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Decitabine 20 mg/m^2 is the first listed.
NCT02472145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02472145 about?
NCT02472145 is a clinical study titled "An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy". The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to as...
What is the current status of trial NCT02472145?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 326 participants. The study started on 2015-08-04. Estimated completion is 2018-01-25.
What interventions are being tested in trial NCT02472145?
The interventions under investigation include: Decitabine 20 mg/m^2 (DRUG), Talacotuzumab 9 mg/kg (DRUG).
Who is sponsoring clinical trial NCT02472145?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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