Phase 1 Study of CC-486 in Japanese Subjects With Hematological Neoplasms

Status Terminated

Clinical Trial Summary

To identify the maximum tolerated dose (MTD) of oral azacitidine on different treatment schedules in Japanese subjects with hematological neoplasms

Clinical Trial Description

This is a phase 1, multicenter, open-label, dose-escalation study that will evaluate the maximum tolerated dose (MTD), safety, pharmacokinetics, and preliminary efficacy of CC-486 in Japanese subjects with hematological neoplasms including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), acute myeloid leukemia (AML), multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL). A standard phase 1 design for MTD determination, an open label, dose ascending, "3 + 3" design, is adopted in this study. This study consists of screening phase, MTD determination phase, and treatment phase. Each subject continues study treatment until documentation of progressive disease or discontinuation of study treatment for any reason. Originally only MDS subjects were targeted and the MTD of CC-486 when administered once daily (QD) for 21 days in a 28-day cycle would be evaluated in this study. Currently CC-486 is being clinically developed with both 14-day and 21-day dosing schedules in various diseases. This study was suspended to amend protocol to evaluate the MTD on these different dosing schedule in larger population. This study was re-opened after amended protocol was approved by institutional review board at study site. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01908387
Study type	Interventional
Source	Celgene
Contact
Status	Terminated
Phase	Phase 1
Start date	July 2013
Completion date	July 2015

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