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

NCT02038777

CompletedPhase 1

Sponsor: Pfizer

Conditions: Acute Myeloid Leukemia

Interventions: PF-04449913, PF-04449913, Low dose ARA-C (LDAC), PF-04449913, Daunorubicin

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
* Patients with AML who are newly diagnosed and previously untreated for azacitidine 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 (9)

Nagoya, Aichi-ken, Japan
Kobe, Hyōgo, Japan
Sendai, Miyagi, Japan
Bunkyo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Yamagata, Yamagata, Japan
Akita, Japan
Fukuoka, Japan
Tokyo, Japan