NCT02038777CompletedPhase 1
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 · Last updated 26 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 14 Jan 2014
- Start date
- 25 Mar 2014
- Primary completion date
- 12 Feb 2021
- Lead sponsor
- Pfizer
- NCT number
- NCT02038777
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 48
- From 25 Mar 2014 to the primary completion date, 12 Feb 2021
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akita University Hospital Coordinator of this site? Confirm its status | Akita | Japan | Unknown status |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Japanese Red Cross Nagoya First Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Yamagata University Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.