Clinical trial · Interventional
A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-04449913 (GLASDEGIB), AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS A SINGLE AGENT IN JAPANESE PATIENTS WITH SELECT HEMATOLOGIC MALIGNANCIES AND IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW-DOSE ARA-C, OR AZACITIDINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| LDAC | Drug | — | UNRESOLVED |
| Low dose ARA-C (LDAC) | Drug | Cytarabine | ALIAS |
| PF-04449913 | Drug | Glasdegib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Monotherapy Cohort
- description
- PF-04449913 Monotherapy
- interventionNames
- Drug: PF-04449913
- type
- EXPERIMENTAL
- label
- Combination Cohort 1
- description
- PF-04449913 in combination with low dose ARA-C (LDAC)
- interventionNames
- Drug: PF-04449913
- Drug: Low dose ARA-C (LDAC)
- type
- EXPERIMENTAL
- label
- Combination Cohort 2
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available