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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 SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039