Clinical trial NCT02632721: A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Official title: An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia, Myeloid, Acute
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase I Dose Escalation: Open-label, single-arm, dose escalation

- To determine the maximum tolerated dose (MTD) and the recommended dose for Phase I Extension (RExP1D)

Phase I Extension: Open-label, two consecutive groups (cohort A and B) - To collect additional data on safety, pharmacokinetics and efficacy and to decide if the RExP1D will become the Recommended Phase II Dose (RP2D)

Phase II: Open-label, two-arm randomized

- To investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion criteria:

1)

Phase I Dose Escalation:

* Male or female patients \>/= 18 years of age with relapsed or refractory AML
* Male or female patients \>/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy

Phase I Extension and Phase II:

-- Male or female patients \>/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy

2) Histologically or cytologically confirmed AML according to the WHO classification 3) Patients must be eligible for treatment with decitabine 4) Eastern co-operative oncology group (ECOG) performance score \</=2 at screening Further inclusion criteria apply.

Exclusion criteria:

1. Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
2. Patients who are candidates for allogeneic stem cell transplantation.
3. Active chronic graft versus host disease requiring immunosuppressive treatment.
4. Phase I extension and Phase II only:

   Prior treatment with a hypomethylating agent, such as prior treatment for Myelodysplastic Syndrome (MDS).
5. Prior treatment with Cluster of differentiation 33 (CD33) antibody. Further exclusion criteria apply.

Primary outcomes:
measure: Phase I: Number of Patients With Dose Limiting Toxicity (DLT(s)) During First Treatment Cycle
timeFrame: Up to 28 days (first treatment cycle).
measure: Phase I: Maximum Tolerated Dose (MTD) of BI 836858 in Combination With Decitabine
timeFrame: From first drug administration until end of treatment, up to 941 days.
Secondary outcomes:
measure: Phase 1: Number of Patients With Objective Response (CR + CRi)
timeFrame: From start of treatment until the earliest of progression, death or end of trial, up to 971 days.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Valencia
country: Spain
facility: Hospital Politècnic La Fe
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: