Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
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
Princess Margaret Hopsital
🇨🇦Toronto, Ontario, Canada
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Duke Univeristy Medical Center
🇺🇸Durham, North Carolina, United States
Taussig Cancer Institute
🇺🇸Cleveland, Ohio, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
M.D. Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Montefiore Medical Center Weiler Division
🇺🇸Bronx, New York, United States
Emory University Clinic
🇺🇸Atlanta, Georgia, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Washington University, Oncology/Bone Marrow Transplant
🇺🇸St Louis, Missouri, United States
Monter Cancer Center
🇺🇸Lake Success, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Erasmus MC
🇳🇱Rotterdam, Netherlands
VUMC
🇳🇱Amsterdam, Netherlands
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
John Theurer Cancer Center, Hackensack University Medical Center,
🇺🇸Hackensack, New Jersey, United States