A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasms; Hematologic Neoplasms
Intervention: PF-04449913; PF-04449913; Low dose ARA-C (LDAC); PF-04449913; Daunorubicin; Cytarabine; PF-04449913; Azacitidine; PF-04449913; LDAC
Intervention description: PF-04449913 administered orally and continuously in 28 day cycles.; PF-04449913 administered orally and continuously in 28 day cycles.; Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.; PF-04449913 administered orally and continuously in 28 day cycles.; Daunorubicin given using 60 mg/m2 for 3-days.; Cytarabine 100 mg/m2 on days 1 through 7.; PF-04449913 administered orally and continuously in 28 day cycles.; Azacitidine Combination Cohort; Azacitidine 75 mg/m2 for 7 days.; PF-04449913 administered orally and continuously in 28 day cycles.; Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
Intervention MeSH terms: Cytarabine; Azacitidine; Daunorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: MTD was determined in monotherapy cohort. Then two combination cohorts (Combination Cohorts 1 and 2) were added to evaluate the safety of glasdegib administered with chemotherapies. Another combination cohort (Combination Cohort 3) was added to evaluate the safety of glasdegib administered with Azacitidine. Then, Continuation Cohort which allows one Japanese patient enrolled from another trial in the same project was added. Afther that, Expansion Cohort of LDAC Combination for efficacy was added.
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hematologic Malignancies

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.
    

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