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A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies

NCT02038777 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-26

Study results available
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Summary

This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients. PF-04449913 will be administered orally as a single agent in patients with select advanced hematologic malignancies, or in combination with LDAC \[Low-Dose Ara-C\] or cytarabine and daunorubicin in previously untreated patients with AML \[Acute Myeloid Leukemia\] or high-risk MDS \[Myelodysplastic Syndrome\], or in combination with azacitidine in previously untreated patients with AML.

Conditions

Interventions

DRUG

PF-04449913

PF-04449913 administered orally and continuously in 28 day cycles.

DRUG

PF-04449913

PF-04449913 administered orally and continuously in 28 day cycles.

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 in 28 day cycles.

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 in 28 day cycles.

DRUG

Azacitidine

Azacitidine Combination Cohort; Azacitidine 75 mg/m2 for 7 days.

DRUG

PF-04449913

PF-04449913 administered orally and continuously in 28 day cycles.

DRUG

LDAC

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-25
Primary Completion
2021-02-12
Completion
2023-12-28
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02038777 on ClinicalTrials.gov