A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Hematologic Malignancies
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PF-04449913 Type: Drug
Name: PF-04449913 Type: Drug
Name: Low dose ARA-C (LDAC) Type: Drug
Name: PF-04449913 Type: Drug
Name: Daunorubicin Type: Drug
Name: Cytarabine Type: Drug
Overall Status
Recruiting
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].
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies for monotherapy cohort.

- Patients with AML or High-Risk MDS who are newly diagnosed and previously untreated for combination cohort.

- ECOG [Eastern Cooperative Oncology Group] performance status 0 to 2

- Adequate organ function

Exclusion Criteria:

- Patients with active CNS disease

- Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical

- Patient has an active, life threatening or clinically significant uncontrolled systemic infection
Locations
Kobe University Hospital
Kobe-shi, Hyogo, Japan
Status: Recruiting
Tohoku University Hospital
Sendai, Miyagi, Japan
Status: Recruiting
National Cancer Center
Chuo-ku, Tokyo, Japan
Status: Recruiting
Kyushu University Hospital
Fukuoka, Japan
Status: Recruiting
Start Date
March 2014
Completion Date
February 2017
Sponsors
Pfizer
Source
Pfizer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page