Phase 1 Open-label Dose Escalation and Expansion Study of ZEN003365 in Subjects With Relapsed or Refractory Lymphoproliferative Malignancies or Acute Myeloid Leukemia
Overview
- Phase
- Phase 1
- Intervention
- ZEN003365
- Conditions
- Lymphoproliferative Malignancies
- Sponsor
- Zenith Epigenetics
- Locations
- 4
- Primary Endpoint
- Dose escalation stage - The safety of orally administered ZEN003365, assessed by frequency of adverse events, including worsening of medical conditions/diseases
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
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 malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Arms & Interventions
Dose Escalation Stage - ZEN003365
ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients
Intervention: ZEN003365
Dose Expansion Stage - ZEN003365
ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients
Intervention: ZEN003365
Outcomes
Primary Outcomes
Dose escalation stage - The safety of orally administered ZEN003365, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Time Frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose escalation stage - To characterize the DLTs of orally administered ZEN003365, using NCI CTCAE v4.03
Time Frame: The first 25 days of at least 12 doses of ZEN003365
Dose expansion stage - Preliminary evidence of the antitumor activity of orally administered ZEN003365 in selected patients, assessed by objective response, duration of objective response and progression-free survival
Time Frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose expansion stage - The safety of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Time Frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Secondary Outcomes
- Dose escalation stage - To characterize the pharmacokinetics (PK) of orally administered ZEN003365 in patients, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio(From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average))
- Dose expansion stage - To characterize the PK of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio(From Screening Visit through 40 days after the last day of treatment with ZEN003365 (19 weeks, average))