Spots Global Cancer Trial Database for Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML
Official Title: The OPAL Study: A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of Tosedostat (CHR-2797) in Elderly Subjects With Treatment Refractory or Relapsed Acute Myeloid Leukemia
Study ID: NCT00780598
Interventions
Study Description
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.
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Duke Univeristy Medical Center, Durham, North Carolina, United States
Taussig Cancer Institute, Cleveland, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Froedtert Hospital, Milwaukee, Wisconsin, United States
Princess Margaret Hopsital, Toronto, Ontario, Canada
Royal Victoria Hospital, Montreal, Quebec, Canada
VUMC, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Contact Details
Name: Jorge E Cortes, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Karen Yee, MD
Affiliation: Princess Margaret Hospital, Canada
Role: PRINCIPAL_INVESTIGATOR
Name: Eric Feldman, MD
Affiliation: Weill Cornell Medical College - New York Presbyterian Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: David Rizzieri, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Joseph Jurcic, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Larson, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
Name: Hanna J Khoury, MD
Affiliation: Emory University Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Harry Erba, MD
Affiliation: University of Michigan
Role: PRINCIPAL_INVESTIGATOR
Name: Samir Parekh, MD
Affiliation: Montefiore Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Aarthi Shenoy, MD
Affiliation: Medstar Health Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Anjali Advani, MD
Affiliation: Taussig Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Shambavi Richard, MD
Affiliation: Stony Brook University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Allen, MD
Affiliation: Monter Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ehab Attalah, MD
Affiliation: Froedtert Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: John Storring, MD
Affiliation: Royal Victoria Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Gerrit J Ossenkoppele, MD
Affiliation: VUMC
Role: PRINCIPAL_INVESTIGATOR
Name: Pieter Sonneveld, MD
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Gary Schiller, MD
Affiliation: UCLA Division of Hematology/oncology, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Westervelt, MD
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Julio Hajdenberg, MD
Affiliation: MD Anderson Cancer centre, Orlando, FL
Role: PRINCIPAL_INVESTIGATOR
Name: Stuart Goldberg, MD
Affiliation: John Theurer Cancer Center, Hackensack NJ
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
