Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML

Summary

The purpose of this study is to evaluate the efficacy and safety of tosedostat in elderly patients suffering from refractory or relapsed AML.

Conditions

• Acute Myeloid Leukemia
• AML

Interventions

DRUG

Tosedostat

In Part A, approximately 70 subjects will be randomized to one of 2 dose regimens of tosedostat which will be administered orally, once daily. The dose regimens of tosedostat will be: * 120 mg for 6 months once daily, OR * 240 mg (induction dose) once daily for 2 months, followed by 120 mg(maintenance dose) for 4 months In Part B a further 130 subjects will receive the dose regimen of tosedostat identified in Part A as being appropriate, based on the interim analysis during Part A.

Sponsors & Collaborators

• Quintiles, Inc.

  collaborator INDUSTRY

• Chroma Therapeutics

  lead INDUSTRY

Principal Investigators

• Jorge E Cortes, MD · M.D. Anderson Cancer Center

• Karen Yee, MD · Princess Margaret Hospital, Canada

• Eric Feldman, MD · Weill Cornell Medical College - New York Presbyterian Hospital

• David Rizzieri, MD · Duke University

• Joseph Jurcic, MD · Memorial Sloan Kettering Cancer Center

• Richard Larson, MD · University of Chicago

• Hanna J Khoury, MD · Emory University Clinic

• Harry Erba, MD · University of Michigan

• Samir Parekh, MD · Montefiore Medical Center

• Aarthi Shenoy, MD · Medstar Health Research Institute

• Anjali Advani, MD · Taussig Cancer Institute

• Shambavi Richard, MD · Stony Brook University Medical Center

• Steven Allen, MD · Monter Cancer Center

• Ehab Attalah, MD · Froedtert Hospital

• John Storring, MD · Royal Victoria Hospital, Belfast

• Gerrit J Ossenkoppele, MD · VUMC

• Pieter Sonneveld, MD · Erasmus Medical Center

• Gary Schiller, MD · UCLA Division of Hematology/oncology, Los Angeles

• Peter Westervelt, MD · Washington University School of Medicine

• Julio Hajdenberg, MD · MD Anderson Cancer centre, Orlando, FL

• Stuart Goldberg, MD · John Theurer Cancer Center, Hackensack NJ

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• United States
• Canada
• Netherlands

Study Locations