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NCT02632721 · ClinicalTrials.gov registry record · Phase 1
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT02632721 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 49 participants.
The verdict
NCT02632721, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
Phase I Dose Escalation: Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
Interventions
- DRUG Decitabine
- DRUG BI 836858
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2016-06-16 |
| Est. Completion | 2023-01-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02632721
The ClinicalTrials.gov registry entry for NCT02632721 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 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 is the first listed.
NCT02632721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02632721 about?
NCT02632721 is a clinical study titled "A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)". Phase I Dose Escalation: Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objec...
What is the current status of trial NCT02632721?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2016-06-16. Estimated completion is 2023-01-16.
What interventions are being tested in trial NCT02632721?
The interventions under investigation include: Decitabine (DRUG), BI 836858 (DRUG).
Who is sponsoring clinical trial NCT02632721?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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