A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

June 27, 2012

Primary Completion Date

January 3, 2017

Study Completion Date

March 4, 2019

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28-days.

DRUG

Low dose ARA-C (LDAC)

Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.

DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days.

DRUG

Decitabine

Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days

DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days

DRUG

Daunorubicin

Daunorubicin given using 60 mg/m2 for 3-days

DRUG

Cytarabine

Cytarabine 100 mg/m2 on days 1 through 7

DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days

DRUG

Daunorubicin

Daunorubicin given using 60 mg/m2 for 3-days

DRUG

Cytarabine

Cytarabine 100 mg/m2 on days 1 through 7

DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913)

DRUG

Low dose ARA-C (LDAC)

Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.

Trial Locations (81)

10126

A.O. Citta della Salute e della Scienza di Torino - S.C. Ematologia, Torino

12203

Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin, Berlin

13353

Charite - Universitatsmedizin Berlin, Berlin

14263

Roswell Park Cancer Institute, Buffalo

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

24105

Universitaetsklinikum Schleswig-Holstein, Kiel

28034

Hospital Ramon y Cajal, Madrid

30322

Emory University Hospital, Atlanta

Investigational Drug Service, Emory University Clinic, Atlanta

The Emory Clinic, Atlanta

Winship Cancer Institute, Emory University, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

33100

Azienda Sanitaria Universitaria Integrata di Udine, Udine

33612

H.Lee Moffitt Cancer Center and Research Institute, Tampa

35233

University of Alabama at Birmingham, Birmingham

35249

University of Alabama at Birmingham, Birmingham

37203

Centennial Medical Center, Nashville

Sarah Cannon Research Institute, Nashville

Tennessee Oncology, PLLC, Nashville

39120

Universitaetsklinikum Magdeburg A.oe.R., Magdeburg

40138

Policlinico S. Orsola-Malpighi, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

44195

Cleveland Clinic Cancer Institute, Cleveland

46026

Hospital Universitario y Politecnico La Fe, Valencia

48109

University of Michigan Health System, Ann Arbor

48149

Universitaetsklinikum Muenster, Münster

55131

Johannes Gutenberg-Universitaet Mainz, Mainz

60590

Johann Wolfgang Goethe University, Frankfurt am Main

60611

Northwestern Medical Faculty Foundation, Chicago

Northwestern Medicine Developmental Therapeutics Institute, Chicago

Northwestern Memorial Hospital, Chicago

60637

The University of Chicago Medical Center, Chicago

The University of Chicago's Medical Center, Chicago

63110

Barnes Jewish Hospital North Campus, St Louis

Barnes-Jewish Hospital, St Louis

Washington University School of Medicine - Division of Bone Marrow Transplant & Leukemia, St Louis

Washington University School of Medicine, Siteman Cancer Center, St Louis

63141

Siteman Cancer Center - West County, Creve Coeur

66160

University of Kansas Hospital, Kansas City

66205

University of Kansas Clinical Research Center, Fairway

University of Kansas Cancer Center and Medical Pavilion, Westwood

77030

The University of Texas, MD Anderson Cancer Center, Houston

80045

University of Colorado Denver, Aurora

University of Colorado Hospital, Aurora

89081

Universitaetsklinikum Ulm, Ulm

Universitaetsklinikum Ulm, Ulm

90033

Keck Hospital of USC, Los Angeles

LAC & USC Medical Center, Los Angeles

USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

90095

Ronald Reagan UCLA Medical Center Drug Information Center, Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles

UCLA Drug lnformation/lnvestigational Drugs, Los Angeles

UCLA Hematology/Oncology Clinic, Los Angeles

92037

UC San Diego Medical Center - La Jolla, La Jolla

92103

UC San Diego Medical Center - Hillcrest, San Diego

98109

University of Washington-Seattle Cancer Care Alliance, Seattle

98195

University of Washington Medical Center, Seattle

35249-6909

University of Alabama at Birmingham, Birmingham

92037-0845

UC San Diego Moores Cancer Center - Investigational Drug Services, La Jolla

92093-0698

UC San Diego Moores Cancer Center, La Jolla

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02215

Dana Farber Cancer Institute (DFCI), Boston

48109-2800

University of Michigan Comprehensive Cancer Center Clinical Trials Office, Ann Arbor

07601

Hackensack University Medical Center, Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

L8V 5C2

Juravinski Cancer Centre @ Hamilton Health Sciences, Hamilton

J4V 2H1

Centre de Sante et de Services Sociaux (CSSS) Champlain - Charles-Le Moyne, Greenfield Park

00161

"Policlinico Universitario Umberto I Universita degli Studi La Sapienza Sezione di Ematologia", Rome

80-952

Uniwersyteckie Centrum Kliniczne Gdanskiego Uniwersytetu Medycznego, Gdansk

93-513

Oddzial Hematologii Z pododzialem chemioterapii-Klinika Hematologii Wojewodzkie Wielospecjalistyczne, Lodz

53-439

Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01546038 - A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter