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

Tracking Information

First Received Date ^ICMJE

September 16, 2002

Last Updated Date

September 21, 2009

Start Date ^ICMJE

January 2002

Primary Completion Date

September 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00045942 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acute Myeloid Leukemia
Myelodysplastic Syndromes

Intervention ^ICMJE

Drug: PKC412, an inhibitor of FLT3

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2006

Primary Completion Date

September 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00045942

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CPKC412 2104

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Dana-Farber Cancer Institute
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
University of California, Los Angeles

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP