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A Phase 1B/2 Study To Evaluate The Safety And Efficacy Of PF-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-C Or Decitabine In Patients With Acute Myeloid Leukemia Or High Risk Myelodysplastic Syndrome


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

A Phase 1B/2 Study To Evaluate The Safety And Efficacy Of PF-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-C Or Decitabine In Patients With Acute Myeloid Leukemia Or High Risk Myelodysplastic Syndrome


Inclusion Criteria:



- Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the
WHO 2008 Classification and previously untreated.

- Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who
may have had one prior regimen with commercially available agents for the treatment
of their prior hematologic disease. The patients may not have had a prior therapy
for their AML.

- AML patients include de novo AML, AML evolving from MDS or other AHD and AML after
previous cytotoxic therapy or radiation (secondary AML)

- For a diagnosis of AML, a bone marrow blast count of 20% or more is required.

- For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have
10-19% bone marrow blasts

- Adequate Organ Function

- ECOG Performance Status 0, 1, or 2

Exclusion Criteria:

- AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic
translocation.

- Patients in whom, at the time of study entry, a stem cell transplant is planned
within the next 6 months.

- Patients with known active uncontrolled central nervous system (CNS) leukemia.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with Dose-limiting toxicities (DLT)

Outcome Time Frame:

1 -year

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1371003

NCT ID:

NCT01546038

Start Date:

July 2012

Completion Date:

November 2015

Related Keywords:

  • Acute Myeloid Leukemia
  • Hedgehog Inhibitor
  • Acute Myeloid Leukemia
  • Myelodysplastic syndrome
  • Intensive chemotherapy
  • LDAC
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Livingston, New Jersey  07039