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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: Clinical Trial Phase 1 study, sponsored by Boehringer Ingelheim.
NCT02003573 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with decitabine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and decitabine at which the incidence of DLT was ≤17%
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 |
Why NCT02003573 stopped before completion
NCT02003573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which decitabine iv is the first listed.
NCT02003573 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02003573's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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