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A Study To Evaluate PF-044499...

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

Last Updated: 2020-03-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-27

Study Completion Date

2019-03-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (Phase 1B)

PF-04449913 in combination with low dose ARA-C (LDAC)

Group Type EXPERIMENTAL

PF-04449913

Intervention Type DRUG

PF-04449913 administered orally and continuously for 28-days.

Low dose ARA-C (LDAC)

Intervention Type DRUG

Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.

Arm B (Phase 1B)

PF-04449913 in combination with Decitabine

Group Type EXPERIMENTAL

PF-04449913

Intervention Type DRUG

PF-04449913 administered orally and continuously for 28 days.

Decitabine

Intervention Type DRUG

Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days

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.

Group Type EXPERIMENTAL

PF-04449913

Intervention Type DRUG

PF-04449913 administered orally and continuously for 28 days

Daunorubicin

Intervention Type DRUG

Daunorubicin given using 60 mg/m2 for 3-days

Cytarabine

Intervention Type DRUG

Cytarabine 100 mg/m2 on days 1 through 7

P2 Fit (Phase 2 Single Arm)

Group Type EXPERIMENTAL

PF-04449913

Intervention Type DRUG

PF-04449913 administered orally and continuously for 28 days

Daunorubicin

Intervention Type DRUG

Daunorubicin given using 60 mg/m2 for 3-days

Cytarabine

Intervention Type DRUG

Cytarabine 100 mg/m2 on days 1 through 7

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).

Group Type OTHER

PF-04449913

Intervention Type DRUG

PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913)

Low dose ARA-C (LDAC)

Intervention Type DRUG

Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.

Interventions

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PF-04449913

PF-04449913 administered orally and continuously for 28-days.

Intervention Type DRUG

Low dose ARA-C (LDAC)

Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.

Intervention Type DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days.

Intervention Type DRUG

Decitabine

Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days

Intervention Type DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days

Intervention Type DRUG

Daunorubicin

Daunorubicin given using 60 mg/m2 for 3-days

Intervention Type DRUG

Cytarabine

Cytarabine 100 mg/m2 on days 1 through 7

Intervention Type DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days

Intervention Type DRUG

Daunorubicin

Daunorubicin given using 60 mg/m2 for 3-days

Intervention Type DRUG

Cytarabine

Cytarabine 100 mg/m2 on days 1 through 7

Intervention Type DRUG

PF-04449913

PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913)

Intervention Type DRUG

Low dose ARA-C (LDAC)

Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

UC San Diego Moores Cancer Center - Investigational Drug Services

La Jolla, California, United States

Site Status

UC San Diego Medical Center - La Jolla

La Jolla, California, United States

Site Status