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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase 1 Open-label Dose Escalation and Expansion Study of ZEN003365 in Subjects With Relapsed or Refractory Lymphoproliferative Malignancies or Acute Myeloid Leukemia

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).

Detailed Summary:
Sponsor: Zenith Epigenetics

Current Primary Outcome:

  • 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) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 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 [ Time Frame: From Screening Visit through 40 days after the last day of treatment with ZEN003365 (19 weeks, average) ]


Original Secondary Outcome: Same as current

Information By: Zenith Epigenetics

Dates:
Date Received: August 28, 2014
Date Started: October 2014
Date Completion: January 2017
Last Updated: November 12, 2014
Last Verified: November 2014