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

Summary

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.

Conditions

• Acute Myeloid Leukemia

Interventions

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

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)

DRUG

Low dose ARA-C (LDAC)

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

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-27

Primary Completion

2017-01-03

Completion

2019-03-04

Countries

• United States
• Canada
• Germany
• Italy
• Poland
• Spain

Study Locations