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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02632721
Other study ID # 1315.2
Secondary ID 2015-002892-30
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 16, 2016
Est. completion date January 16, 2023

Study information

Verified date February 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date January 16, 2023
Est. primary completion date January 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Decitabine

BI 836858


Locations

Country Name City State
Germany Universitätsklinikum Augsburg Augsburg
Germany Vivantes Netzwerk für Gesundheit GmbH Berlin
Germany Universitätsklinikum Carl Gustav Carus Dresden Dresden
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Universitätsklinikum Jena Jena
Germany Universitätsklinikum Münster Münster
Italy A.O. Spedali Civili di Brescia Brescia
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Politècnic La Fe Valencia
United States Northwestern University Chicago Illinois
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Mayo Clinic Cancer Center Jacksonville Florida
United States Northwell Health Lake Success New York

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: Number of Patients With Dose Limiting Toxicity (DLT(s)) During First Treatment Cycle Number of patients with dose limiting toxicity (DLT(s)) for BI 836858 in combination with decitabine during first treatment cycle (Phase 1).
DLT was defined as any non-disease-related non-haematological adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher. Expected non-haematological disease-related AEs were not to be regarded as a DLT.
These included complications resulting from haematological AEs such as:
Bleeding and complications from bleeding due to thrombocytopenia as defined by the Investigator,
Infection and complications from infections due to neutropenia as defined by the Investigator,
Constitutional symptoms due to anaemia as defined by the Investigator
Up to 28 days (first treatment cycle).
Primary Phase I: Maximum Tolerated Dose (MTD) of BI 836858 in Combination With Decitabine The Maximum tolerated dose (MTD) of BI 836858 in combination with decitabine was estimated after the dose escalation part of the trial obtaining on the basis of dose limiting toxicities (DLT(s)) observed during the first treatment cycle. However, for those patients who receive more than one cycle of the combination treatment, all adverse events that constitute a DLT will be considered for re-estimation of the MTD based on the Bayesian logistic regression model (BLRM). The MTD is defined as the highest dose of BI 836858 (in combination with decitabine) with less than 25% risk of the true DLT rate being above 33% during the MTD evaluation period. From first drug administration until end of treatment, up to 941 days.
Secondary Phase 1: Number of Patients With Objective Response (CR + CRi) Number of patients with objective response (Complete remission (CR) + complete remission with incomplete remission (CRi)).
CR was defined as bone marrow (BM) blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L [1,000/µL]; platelet count > 100 x 109/L [100,000/µL]; independence of red blood cells transfusions (no transfusion for 1 week prior to the assessment). No minimum duration of response is required.
CRi was defined as all CR criteria except for residual neutropenia (< 1.0 x 109/L [1,000/µL]) or thrombocytopenia (< 100 x 109/L [100,000/µL]).
From start of treatment until the earliest of progression, death or end of trial, up to 971 days.
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