Phase 1 Study Evaluating ZEN003365 in Relapsed/Refractory Lymphoproliferative Malignancies or Relapsed/Refractory AML

• Status: Withdrawn
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine safety, tolerability, dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zenith Epigenetics

Criteria

Inclusion Criteria:

Dose Escalation and Expansion Stages:

• ECOG performance status ≤ 1 for LPM patients, ≤ 2 for AML patients

• Age 18 years or older

• Adverse events (AEs), except for alopecia, from any previous treatments must have recovered to eligibility levels from prior toxicity

• Adequate renal, hepatic and coagulation function, as specified per protocol

• Written informed consent granted prior to any study-specific screening procedures

LPM Patients:

• Histologically confirmed lymphoproliferative malignancy

• Have received prior protocol-specified disease-dependent prior treatments

• Have measurable disease

• Platelets ≥ 75,000/µL (≥50,000/µL if bone marrow involvement), absolute neutrophil count (ANC) ≥ 1,000/ µL, and hemoglobin (Hgb) ≥ 8 g/dL

• Patients must have been off previous anticancer therapy for at least 3 weeks or 5 half-lives, whichever is longer, and the subject must have recovered to eligibility levels from prior toxicity

AML:

• Refractory or relapsed AML patients, without curative intent, e.g., not a stem cell transplant candidate

• Any prior chemotherapy must have been completed ≥ 2 weeks, any therapy with biologics must have been completed ≥ 4 weeks prior to day 1 of study treatment, and the participant must have recovered to eligibility levels from prior toxicity

• Blast count ≤ 10,000/µL prior to initiation of therapy

Exclusion Criteria

Dose Escalation and Expansion Stages:

• Prior exposure to a BET inhibitor

• Prior allogeneic hematopoietic cell transplant

• Chronic graft versus host disease

• Known, active fungal, bacterial, and/or viral infection

• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

• Current subdural hematoma

• CNS or leptomeningeal metastases

• Requirement for medications or agents known to be sensitive CYP3A4 substrate drugs, CYP3A4 substrate drugs with a narrow therapeutic range or to be strong inhibitors/inducers of CYP3A4

• Requirement for immunosuppressive agents

• Evidence of significant cardiovascular disease or significant screening ECG abnormalities

• Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient.

AML patients:

• Acute promyelocytic leukemia (APL)

• Chronic myeloid leukemia (CML) in blast crisis