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NCT02003573 · ClinicalTrials.gov registry record · Phase 1
Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02003573 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 13 participants.
The verdict
NCT02003573, a Phase 1 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status. MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML \>= 65 years of age and considered ineligible for standard intensive therapy.
Interventions
- DRUG decitabine iv
- DRUG volasertib iv infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-01-29 |
| Est. Completion | 2016-05-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02003573
The ClinicalTrials.gov registry entry for NCT02003573 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which decitabine iv is the first listed.
NCT02003573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02003573 about?
NCT02003573 is a clinical study titled "Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)". Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intens...
What is the current status of trial NCT02003573?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-01-29. Estimated completion is 2016-05-15.
What interventions are being tested in trial NCT02003573?
The interventions under investigation include: decitabine iv (DRUG), volasertib iv infusion (DRUG).
Who is sponsoring clinical trial NCT02003573?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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