BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse

Phase 1

Completed

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: BI 836858

• Registration Number: NCT01690624
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are in complete remission with high risk to relapse may be eligible for this trial. The trial will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-13
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Status Verified: 2018-05
• Primary Completion: 2018-05-21
• Study Completion: 2018-05-21
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with relapsed or refractoryAML	BI 836858	Patients with acute myeloid leukemia who have relapsed after 1 prior treatment.

Primary Outcome Measures

Name	Time	Method
Number of patients with dose limiting toxicity during maximum tolerated dose evaluation for patients with refractory or relapsed acute myeloid leukemia	up to 4 weeks
Determination of the maximum tolerated dose of BI 836858	up to 4 weeks
Number of patients with dose limiting toxicity during maximum tolerated dose evaluation for acute myeloid leukemia patients in complete remission with high risk to relapse	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Mean residence time after intravenous infusion (MRT)	up to 168 hours
Total plasma clearance (CL)	up to 168 hours
Apparent volume of distribution during the terminal phase (Vz)	up to 168 hours
Volume of distribution after intravenous infusion at steady state (Vss)	up to 168 hours
Area under the plasma concentration-time curve over the time interval of one week (AUC0-168)	up to 168 hours
Maximum measured plasma concentration (Cmax)	up to 168 hours
Time from dosing to the maximum plasma concentration (tmax)	up to 168 hours
Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-infinity)	up to 168 hours
Area under the plasma concentration-time curve over the time interval of one treatment cycle (AUC0-tz)	up to 336 hours
Terminal half-life (t1/2)	up to 168 hours
Progression free survival for acute myeloid leukemia patients in complete remission with high risk to relapse	up to 22 months
Area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable data point (AUC0-tz)	up to 168 hours
Progression free survival for patients with refractory or relapsed acute myeloid leukemia	up to 22 months
Best overall response rate according to International Working Group (IWG) criteria (for refractory or relapsed acute myeloid leukemia patients only)	up to 22 months
Time to treatment failure for patients with refractory or relapsed acute myeloid leukemia	up to 22 months
Time to treatment failure for acute myeloid leukemia patients in complete remission with high risk to relapse	up to 22 months

Trial Locations

Locations (5)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States