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

This study has been completed.

First Received: September 16, 2002 Last Updated: September 21, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Collaborators:	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

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

Resource links provided by NLM:

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

Drug Information available for: Cgp 41251

U.S. FDA Resources

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. [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess safety [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]
Determine pharmacodynamic activity [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]
Assess changes in markers of efficacy and toxicity [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	January 2002
Estimated Study Completion Date:	February 2006
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PKC412: Experimental	Drug: PKC412, an inhibitor of FLT3

Eligibility

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

Criteria

Inclusion 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.
Patients with a relevant FLT3-ITD mutation or D835Y point mutation
Patients at least 18 years or older
Patients with WHO performance status of 0 to 2 with a life expectancy of at least 3 months
Patients must not be treated within 4 weeks after any prior therapy
Written informed consent obtained according to local guidelines

Exclusion criteria:

Patients meeting any of the following criteria during screening will be excluded from entry into the study:

Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously.
Female patients who are pregnant or breast feeding, or adults of childbearing age not employing an effective method of birth control.
Concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PKC412.

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, 02115
United States, New York
Memorial Sloan Kettering Cancer Center
New York City, New York, United States, 10065
New York Weill Cornell Medical Center
New York, New York, United States, 10021

Sponsors and Collaborators

Novartis Pharmaceuticals

Dana-Farber Cancer Institute

Memorial Sloan-Kettering Cancer Center

Weill Medical College of Cornell University

University of California, Los Angeles

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CPKC412 2104
Study First Received:	September 16, 2002
Last Updated:	September 21, 2009
ClinicalTrials.gov Identifier:	NCT00045942 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

AML
MDS
high risk myelodysplastic syndrome

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Myelodysplastic Syndromes
Enzyme Inhibitors
Leukemia, Myeloid
4'-N-benzoylstaurosporine

Leukemia, Myeloid, Acute
Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 09, 2009