Trials / Terminated
TerminatedNCT01908387
Phase 1 Study of CC-486 in Japanese Subjects With Hematological Neoplasms
A Phase 1, Multicenter, Open-label, Dose-escalation Study of Oral Azacitidine (CC-486) in Japanese Subjects With Hematological Neoplasms
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Celgene Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To identify the maximum tolerated dose (MTD) of oral azacitidine on different treatment schedules in Japanese subjects with hematological neoplasms
Detailed description
This is a phase 1, multicenter, open-label, dose-escalation study that will evaluate the maximum tolerated dose (MTD), safety, pharmacokinetics, and preliminary efficacy of CC-486 in Japanese subjects with hematological neoplasms including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), acute myeloid leukemia (AML), multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL). A standard phase 1 design for MTD determination, an open label, dose ascending, "3 + 3" design, is adopted in this study. This study consists of screening phase, MTD determination phase, and treatment phase. Each subject continues study treatment until documentation of progressive disease or discontinuation of study treatment for any reason. Originally only MDS subjects were targeted and the MTD of CC-486 when administered once daily (QD) for 21 days in a 28-day cycle would be evaluated in this study. Currently CC-486 is being clinically developed with both 14-day and 21-day dosing schedules in various diseases. This study was suspended to amend protocol to evaluate the MTD on these different dosing schedule in larger population. This study was re-opened after amended protocol was approved by institutional review board at study site.
Conditions
- Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
- Acute Myeloid Leukemia
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Hodgkin Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral azacitidine | 100 mg to 300 mg oral azacitidine once daily for 14 days or 21 days of the initial 28-day cycle |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2013-07-25
- Last updated
- 2015-07-28
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01908387. Inclusion in this directory is not an endorsement.