Phase 1 Study Evaluating ZEN003365 in Relapsed/Refractory Lymphoproliferative Malignancies or Relapsed/Refractory AML
NCT ID: NCT02238522
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2014-10-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation Stage - ZEN003365
ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients
ZEN003365
Dose Expansion Stage - ZEN003365
ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients
ZEN003365
Interventions
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ZEN003365
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Zenith Epigenetics
INDUSTRY
Responsible Party
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Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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Other Identifiers
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ZEN-ONC3365-101
Identifier Type: -
Identifier Source: org_study_id