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A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Last updated on May 25, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

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

NCT01546038
Pfizer
Active, not recruiting
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

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A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
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
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: PF-04449913
    PF-04449913 administered orally and continuously for 28-days.
  • Drug: Low dose ARA-C (LDAC)
    Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
  • Drug: PF-04449913
    PF-04449913 administered orally and continuously for 28 days.
  • Drug: Decitabine
    Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days
  • Drug: PF-04449913
    PF-04449913 administered orally and continuously for 28 days
  • Drug: Daunorubicin
    Daunorubicin given using 60 mg/m2 for 3-days
  • Drug: Cytarabine
    Cytarabine 100 mg/m2 on days 1 through 7
  • Drug: PF-04449913
    PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913)
  • Experimental: Arm A (Phase 1B)
    PF-04449913 in combination with low dose ARA-C (LDAC)
    Interventions:
    • Drug: PF-04449913
    • Drug: Low dose ARA-C (LDAC)
  • Experimental: Arm B (Phase 1B)
    PF-04449913 in combination with Decitabine
    Interventions:
    • Drug: PF-04449913
    • Drug: Decitabine
  • Experimental: Arm C (Phase 1B)
    PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy.
    Interventions:
    • Drug: PF-04449913
    • Drug: Daunorubicin
    • Drug: Cytarabine
  • Experimental: P2 Fit (Phase 2 Single Arm)
    PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy.
    Interventions:
    • Drug: PF-04449913
    • Drug: Daunorubicin
    • Drug: Cytarabine
  • P2 Unfit (Phase 2 Randomized)
    Patients will be randomized 2:1 (low dose ARA-C in combination with PF-04449913: low dose ARA-C alone).
    Interventions:
    • Drug: PF-04449913
    • Drug: Low dose ARA-C (LDAC)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
255
October 17, 2019
January 3, 2017   (Final data collection date for primary outcome measure)

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 with known active uncontrolled central nervous system (CNS) leukemia.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Italy,   Poland,   Spain,   United States
 
 
NCT01546038
B1371003
2012-000684-24 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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