Trials / Completed
CompletedNCT01511289
Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Il-Yang Pharm. Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Conditions
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
- Bone Marrow Diseases
- Hematologic Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Imatinib | 400mg/Tab, QD |
| DRUG | Radotinib | 100mg or 200mg/Capsule, 300mg or 400mg BID |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2015-02-01
- First posted
- 2012-01-18
- Last updated
- 2016-02-24
Locations
22 sites across 4 countries: Indonesia, Philippines, South Korea, Thailand
Source: ClinicalTrials.gov record NCT01511289. Inclusion in this directory is not an endorsement.