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

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Azacitidine; Cytarabine; Daunorubicin

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