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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: LDAC; Drug: PF-04449913; Drug: Daunorubicin; Drug: Azacitidine; Drug: Low dose ARA-C (LDAC); Drug: Cytarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02038777

B1371005

NCT02038777 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Monotherapy Cohort

Experimental group

Description:

PF-04449913 Monotherapy

Treatment:

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Combination Cohort 1

Experimental group

Description:

PF-04449913 in combination with low dose ARA-C (LDAC)

Treatment:

Drug: PF-04449913

Drug: PF-04449913

Drug: Low dose ARA-C (LDAC)

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Combination Cohort 2

Experimental group

Description:

PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy.

Treatment:

Drug: PF-04449913

Drug: PF-04449913

Drug: Cytarabine

Drug: PF-04449913

Drug: Daunorubicin

Drug: PF-04449913

Drug: PF-04449913

Azacitidine Combination Cohort

Experimental group

Description:

PF-04449913 in combination with azacitidine

Treatment:

Drug: PF-04449913

Drug: PF-04449913

Drug: Azacitidine

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Continuation Cohort

Experimental group

Description:

PF-04449913 Monotherapy for one patient rolled-over from another trial in the same project.

Treatment:

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Expansion Cohort of LDAC Combination for Efficacy

Experimental group

Description:

PF-04449913 in combination with LDAC to evaluate efficacy

Treatment:

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Drug: PF-04449913

Drug: LDAC