PKC412 in Patients With Acute Myeloid Leukemia and Patients With Myelodysplastic Syndrome With Either Wild Type or Mutated FLT3

This study has been completed.

Sponsors and Collaborators:	Novartis Dana-Farber Cancer Institute Memorial Sloan-Kettering Cancer Center Weill Medical College of Cornell University University of California, Los Angeles
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00045942

Purpose

Patients who agree to participate in this trial will be screened for the FLT 3 mutation by bone marrow exam. They will have a physical exam, blood test, EKG, chest x-ray, bone marrow aspirate and a pregnancy test. Patients will be required to have weekly blood test and bone marrow aspirate monthly.

Condition	Intervention	Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes	Drug: PKC412, an inhibitor of FLT3	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cgp 41251

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Phase I/II Trial of PKC412 in Patients With Acute Myeloid Leukemia and Patients With Myelodysplastic Syndrome With Either Wild Type or Mutated FLT3

Further study details as provided by Novartis:

Primary Outcome Measures:

To determine the safety, tolerability and pharmacokinetics in AML and high-risk MDS patients when given PKC412 as monotherapy.

Secondary Outcome Measures:

Assess safety
Determine pharmacodynamic activity
Assess changes in markers of efficacy and toxicity

Estimated Enrollment:	20
Study Start Date:	June 2004
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients:

with AML who are not candidates for myelosuppressive chemotherapy or with AML who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with MDS subtypes RAEB, RAEB-T or CMML.

Who 0-2
FLT 3 mutation
AML (MDS patients exempted) must have a total WBC (including blast) of > 5,000
Patients must have a serum creatinine of < 1.5 x ULN, SGOT/SGPT < 3 x ULN and total bilirubin < 2.0 x ULN.

No active infections; no pulmonary infiltrates on CXR know to be new within 4 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045942

Locations

United States, California
UCLA Medical Center
Los angeles, California, United States, 90095
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
United States, New York
Memorial Sloan Kettering Cancer Center
New York City, New York, United States
New York Weill Cornell Medical Center
New York, New York, United States, 10021

Sponsors and Collaborators

Novartis

Dana-Farber Cancer Institute

Memorial Sloan-Kettering Cancer Center

Weill Medical College of Cornell University

University of California, Los Angeles

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CPKC412 2104
Study First Received:	September 16, 2002
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00045942
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

AML
MDS
high risk myelodysplastic syndrome

Study placed in the following topic categories:

Myelodysplastic syndromes
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia
Leukemia, Myeloid

Leukemia, Myeloid, Acute
4'-N-benzoylstaurosporine
Leukemia
Preleukemia
Bone Marrow Diseases
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009