A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)

Boehringer Ingelheim

Status and phase: Completed; Phase 2; Phase 1

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: Decitabine; Drug: BI 836858

Study type: Interventional

Funder types: Industry

Identifiers

NCT02632721

2015-002892-30 (EudraCT Number)

1315.2

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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49 participants in 5 patient groups

Phase I dose escalation: BI 836858 20 mg + decitabine (intensive)

Experimental group

Description:

Dose escalation.

Treatment:

Drug: BI 836858

Drug: Decitabine

Phase I dose escalation: BI 836858 40 mg + decitabine (intensive)

Experimental group

Description:

Dose escalation.

Treatment:

Drug: BI 836858

Drug: Decitabine

Phase I dose escalation: BI 836858 80 mg + decitabine (intensive)

Experimental group

Description:

Dose escalation.

Treatment:

Drug: BI 836858

Drug: Decitabine

Phase I Extension A: BI 836858 80 mg + decitabine (intensive)

Experimental group

Description:

Extension phase.

Treatment:

Drug: BI 836858

Drug: Decitabine

Phase I Extension B: BI 836858 80 mg + decitabine (standard)

Experimental group

Description:

Extension phase.

Treatment:

Drug: BI 836858

Drug: Decitabine