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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia, Myelodysplastic Syndromes

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Trial Information

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

Inclusion Criteria


Inclusion criteria:

1. 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.

2. Patients with a relevant FLT3-ITD mutation or D835Y point mutation

3. Patients at least 18 years or older

4. Patients with WHO performance status of 0 to 2 with a life expectancy of at least 3
months

5. Patients must not be treated within 4 weeks after any prior therapy

6. 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:

1. Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or
stem cell transplant less than 2 months previously.

2. Female patients who are pregnant or breast feeding, or adults of childbearing age not
employing an effective method of birth control.

3. Concurrent severe and/or uncontrolled medical or psychiatric condition which may
interfere with the completion of the study.

4. Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of PKC412.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

baseline, at each cycle during therapy and at study completion

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CPKC412 2104

NCT ID:

NCT00045942

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • AML
  • MDS
  • high risk myelodysplastic syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
UCLA Medical CenterLos Angeles, California  90095-7059
New York Weill Cornell Medical CenterNew York, New York  10021