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An Open-label Phase I/II (Proof of Concept) Trial of PKC412 in Patients With Acute Myeloid Leukemia (AML) and Patients With High Risk Myelodysplastic Syndrome (MDS) With Either Wild Type or Mutated FLT3


Phase 1/Phase 2
14 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

An Open-label Phase I/II (Proof of Concept) Trial of PKC412 in Patients With Acute Myeloid Leukemia (AML) and Patients With High Risk Myelodysplastic Syndrome (MDS) With Either Wild Type or Mutated FLT3


Inclusion Criteria:



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

- Patients with a wild type or mutated FLT3 documented within 14 days prior to start of
study who have not previously received a FLT3 inhibitor.

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

Exclusion Criteria:

- Patients who had prior allergenic, 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 GI function or GI disease that may significant alter the absorption of
PKC412

- Patients who had more than 2 prior regimens for their current relapsed or current
primary refractory disease.

- Uncontrolled active infection

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate preliminary anti-tumor activity in AML and MDS patients with wild type or mutated FLT3 receiving continuous twice-daily oral dose of either 50 or 100 mg who have not previously received a FLT3 inhibitor.

Outcome Time Frame:

Day 28 of Cycle 2

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CPKC412A2104E1

NCT ID:

NCT00977782

Start Date:

March 2003

Completion Date:

October 2008

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • AML
  • MDS
  • FLT3
  • midostaurin
  • wild type FLT3
  • mutated FLT3
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Dana Faber Cancer InstituteBoston, Massachusetts  02115
Memorial Slon-Kettering Cancer CenterNew York, New York  10065
Cornell Comprehensive Cancer CenterNew York, New York  10065