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

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia; AML
• Interventions: Drug: Tosedostat

• Registration Number: NCT00780598
• Lead Sponsor: Chroma Therapeutics

Brief Summary

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

Detailed Description

There is an urgent need for novel compounds and treatment strategies for elderly patients with AML, particularly those with refractory or relapsed disease for whom there are few effective treatment options. Treatment options for elderly patients are further limited by co-morbidity and tolerability constraints.

Tosedostat is a new aminopeptidase inhibitor, which in preclinical experiments has shown potent activity in both in vitro and in vivo cancer models as a single agent. In early clinical studies particularly good results have been observed in refractory and relapsed AML in older patients and these observations form the basis for the current study.

This multi-center, open label phase II study will enrol approximately 70 subjects in Part A and 130 subjects in Part B.

Study Timeline

• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Study Start: 2009-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tosedostat	Tosedostat	oral, once daily administration of tosedostat to evaluate its efficacy, safety and tolerability

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to evaluate the efficacy of tosedostat in elderly subjects with treatment refractory or relapsed AML by measuring CR and CRp.	Months 1, 2, 3 & 6

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of tosedostat in elderly subjects with treatment refractory or relapsed AML	Screening, Days 1, 2, 8, 15, 29, monthly thereafter + unschedulded visits when deemed necessary
To evaluate the efficacy of tosedostat in elderly subjects with treatment refractory or relapsed AML, as determined by measures other than CR and CRp for the type and duration of response	Months 1, 2, 3 & 6

Trial Locations

Locations (21)

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

Washington Cancer Institute; 🇺🇸 Washington, District of Columbia, United States

M.D. Anderson Cancer Center Orlando; 🇺🇸 Orlando, Florida, United States

Emory University Clinic; 🇺🇸 Atlanta, Georgia, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Washington University, Oncology/Bone Marrow Transplant; 🇺🇸 St Louis, Missouri, United States

John Theurer Cancer Center, Hackensack University Medical Center,; 🇺🇸 Hackensack, New Jersey, United States

Montefiore Medical Center Weiler Division; 🇺🇸 Bronx, New York, United States

Monter Cancer Center; 🇺🇸 Lake Success, New York, United States

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