A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
NCT ID: NCT02038777
Last Updated: 2025-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2014-03-25
2023-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Cohort
PF-04449913 Monotherapy
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Combination Cohort 1
PF-04449913 in combination with low dose ARA-C (LDAC)
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Low dose ARA-C (LDAC)
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
Combination Cohort 2
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.
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Daunorubicin
Daunorubicin given using 60 mg/m2 for 3-days.
Cytarabine
Cytarabine 100 mg/m2 on days 1 through 7.
Azacitidine Combination Cohort
PF-04449913 in combination with azacitidine
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Azacitidine
Azacitidine Combination Cohort; Azacitidine 75 mg/m2 for 7 days.
Continuation Cohort
PF-04449913 Monotherapy for one patient rolled-over from another trial in the same project.
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Expansion Cohort of LDAC Combination for Efficacy
PF-04449913 in combination with LDAC to evaluate efficacy
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
LDAC
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
Interventions
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PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Low dose ARA-C (LDAC)
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Daunorubicin
Daunorubicin given using 60 mg/m2 for 3-days.
Cytarabine
Cytarabine 100 mg/m2 on days 1 through 7.
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
Azacitidine
Azacitidine Combination Cohort; Azacitidine 75 mg/m2 for 7 days.
PF-04449913
PF-04449913 administered orally and continuously in 28 day cycles.
LDAC
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Japanese Red Cross Nagoya First Hospital
Nagoya, Aichi-ken, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Akita University Hospital
Akita, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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NCT02038777
Identifier Type: REGISTRY
Identifier Source: secondary_id
B1371005
Identifier Type: -
Identifier Source: org_study_id
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