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Phase I-II

Phase I-II Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

  • Study HIC#:1505015798
  • Last Updated:06/30/2020

Primary Objectives

Phase 1: To assess safety, and to identify the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and the recommended dosing regimen of ASTX660.

Phase 2: To assess preliminary efficacy, as determined by response rate in certain tumor types.

Secondary Objectives

  • To determine the pharmacokinetic (PK) parameters of orally administered ASTX660 in humans.
  • To evaluate other efficacy parameters, such as duration of response and progression-free survival.
  • To evaluate relevant pharmacodynamic (PD) targets and potential biomarkers of ASTX660 activity.
  • Age18 years and older
  • GenderBoth
  • Start Date04/14/2016
  • End Date05/31/2021

Trial Purpose and Description

This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for which standard curative measures do not exist or are no longer effective.

Eligibility Criteria

Inclusion Criteria:

  • Subjects with histologically or cytologically confirmed advanced solid tumors or lymphoma and for whom standard life-prolonging measures are not available.
  • Eastern Cooperative Oncology Group: 0 to 2

Exclusion Criteria:

  • Hypersensitivity to ASTX660, excipients of the drug product, or other components of the study treatment regimen
  • Uncontrolled medical disease(s) or active, uncontrolled infections
  • Life-threatening illness or significant organ system dysfunction
  • A history of, or at risk for, cardiac disease
  • Known history of HIV, or hepatitis B (HBV) or C (HCV)
  • Grade 2 or greater neuropathy
  • Known brain metastases unless stable or previously treated
  • Known significant mental illness
  • Prior anticancer treatments or therapies within specified time windows prior to first dose of study treatment (ASTX660)
  • Pregnant or nursing an infant

Sub-Investigators

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