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

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Acute Myeloid LeukemiaAML
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."

Trial Locations (21)

10065

Memorial Sloan-Kettering Cancer Center, New York

Weill Cornell Medical College - New York Presbyterian Hospital, New York

10461

Montefiore Medical Center Weiler Division, The Bronx

11042

Monter Cancer Center, Lake Success

20010

Washington Cancer Institute, Washington D.C.

27710

Duke Univeristy Medical Center, Durham

30322

Emory University Clinic, Atlanta

32806

M.D. Anderson Cancer Center Orlando, Orlando

44195

Taussig Cancer Institute, Cleveland

60637

University of Chicago Medical Center, Chicago

63110

Washington University, Oncology/Bone Marrow Transplant, St Louis

77030

MD Anderson Cancer Center, Houston

90095

UCLA School of Medicine, Los Angeles

48109-0008

University of Michigan Health System, Ann Arbor

07601

John Theurer Cancer Center, Hackensack University Medical Center,, Hackensack

11794-7007

Stony Brook University Medical Center, Stony Brook

53226-3596

Froedtert Hospital, Milwaukee

M5G 2M9

Princess Margaret Hopsital, Toronto

H3A 1A1

Royal Victoria Hospital, Montreal

1081 HV

VUMC, Amsterdam

3008 AE

Erasmus MC, Rotterdam

Sponsors
All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Chroma Therapeutics

INDUSTRY

NCT00780598 - Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML | Biotech Hunter | Biotech Hunter