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NCT01721876 · ClinicalTrials.gov registry record · Phase 3

Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
666
Enrollment target

NCT01721876 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 666 participants.

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The verdict

NCT01721876, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
666 participants
Enrollment target

Study Summary

To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy

Interventions

  • DRUG Placebo
  • DRUG Cytarabine
  • DRUG Volasertib

Trial Details

FieldValue
Enrollment Target 666 participants
Start Date 2013-01-29
Est. Completion 2021-05-28
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01721876

The ClinicalTrials.gov registry entry for NCT01721876 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 666 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 3 interventions - of which Placebo is the first listed.

NCT01721876 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01721876 about?

NCT01721876 is a clinical study titled "Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)". To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy

What is the current status of trial NCT01721876?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 666 participants. The study started on 2013-01-29. Estimated completion is 2021-05-28.

What interventions are being tested in trial NCT01721876?

The interventions under investigation include: Placebo (DRUG), Cytarabine (DRUG), Volasertib (DRUG).

Who is sponsoring clinical trial NCT01721876?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.