Neoplasms

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Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Translocation, Genetic

Chromosome Aberrations

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Imatinib Mesylate

Enrolled subjects will continue to administer Radotinib 400mg twice daily (800mg/day) orally every 12 hours at regular dosing hours for 12 months.

Dose modification is allowed if the subject cannot comply with the protocol-defined dosing schedule due to hematologic or non-hematologic toxicities and toxicities resolve within 28 days (within 42 days for hematologic toxicities). For radotinib, maximum 2 dose reductions will be allowed by stage to 600mg and to 400mg.

1. Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd.
2. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib)
3. Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder
4. Storage conditions: Store in an airtight light proof container at room temperature.

Radotinib HCl

Na Yun Kim

Kang Hi An

Dong-Wook Kim, MD

Dong-Wook Kim

Dong Wook Kim

In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs

A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib

Incidence rate of BCR-ABL1 point mutations that are newly found during the course of radotinib treatment

To measure the concentration of radotinib in blood

Toxicities will be evaluated in all subjects treated with radotinib.

MCyR is defined as 0\~35% CCyR+PCyR based on ≥20 metaphase myelocytes. Chromosome test results from \<20 metaphase myelocytes will be excluded from the analysis.

CCyR is defined as complete loss of Ph chromosome based on ≥20 metaphase myelocytes. Chromosome test results from \<20 metaphase myelocytes will be excluded from the analysis.

MMR is defined as a ≥3-log reduction in BCR-ABL1 transcript level from the standardized reference or BCR-ABL1/ABL % of ≤0.1% according to the international reference when the level of BCR-ABL1 gene was measured by RQ-PCR, a standardized quantitative genetic method.

OS is defined as the duration from the first day of Radotinib administration to the day of death for certain causes.

PFS is defined as the duration from the first day of Radotinib administration to the earliest day of disease progression or death for certain causes.

Spots Global Cancer Trial Database for radotinib hcl