Status:
WITHDRAWN
Phase 1 Study Evaluating ZEN003365 in Relapsed/Refractory Lymphoproliferative Malignancies or Relapsed/Refractory AML
Lead Sponsor:
Zenith Epigenetics
Conditions:
Lymphoproliferative Malignancies
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ma...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02238522
Start Date
October 1 2014
End Date
January 1 2017
Last Update
November 13 2014
Active Locations (4)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States, 97477
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203