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

October 24, 2024 updated by: Il-Yang Pharm. Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
173

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 11749
        • Recruiting
        • Uijeongbu Eulji Medical Center, Eulji University
        • Contact:
          • Dong-Wook Kim, MD
        • Principal Investigator:
          • Dong-Wook Kim
  • Russian Federation
      • Barnaul, Russian Federation, 656024
        • Not yet recruiting
        • Territorial State Budgetary Institution
      • Kirov, Russian Federation, 610027
        • Recruiting
        • Federal State Budgetary Institution of Science
      • Moscow, Russian Federation, 125167
        • Not yet recruiting
        • Federal State Budgetary Institution
      • Moscow, Russian Federation, 300186883
        • Recruiting
        • Hematology Centre based on City Clin. Hosp. n.a. S.P. Botkin
      • Saint-Petersburg, Russian Federation, 191024
        • Recruiting
        • Federal State Budgetary Institution
      • Saint-Petersburg, Russian Federation, 197341
        • Recruiting
        • Federal State Budgetary Institution
  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Ankara University Medical Faculty
      • Ankara, Turkey
        • Recruiting
        • Gazi University Medical Faculty
      • Istanbul, Turkey
        • Recruiting
        • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
      • Izmir, Turkey
        • Recruiting
        • Ege University Medical Faculty
      • Mersin, Turkey
        • Recruiting
        • Mersin University Medical Faculty
      • Samsun, Turkey
        • Recruiting
        • Ondokuz Mayis Univ. Med. Fac.
  • Ukraine
      • Cherkassy, Ukraine
        • Recruiting
        • CI Cherkasy Regional Oncological Dispensary of CRC
      • Chernihiv, Ukraine
        • Recruiting
        • CTPI Chernihiv Regional Oncological Dispensary
      • Dnipro, Ukraine
        • Recruiting
        • CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC
      • Kyiv, Ukraine
        • Recruiting
        • Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit
      • Lviv, Ukraine
        • Recruiting
        • SI Institute of Blood Pathology and Transfusion Medicine of AMSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients aged 18 years old
  2. Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib
  3. ECOG scale 0, 1 or 2

  4. Chronic phase is defined as all of the following conditions that subjects meet.

    • Blast in peripheral blood and bone marrow <15%
    • The sum of blast and promyelocyte in peripheral blood and bone marrow <30%
    • Basophil in peripheral blood <20%
    • Platelets count ≥50 × 10^9/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia [< 50 × 109/L (< 50,000/mm3)] is acceptable
    • No evidence of involvement of extramedullary leukemia other than enlargements of liver and spleen

  5. Patients who have adequate organ functions as defined below:

    • Total bilirubin < 1.5 × upper limit of normal (ULN)
    • SGOT and SGPT < 2.5× ULN
    • Creatinine < 1.5 × ULN
    • Serum amylase and lipase ≤ 1.5 × ULN
    • Alkaline Phosphatase ≤ 2.5 × ULN (only if not related to the tumor)
  6. Women of childbearing potential should have a negative serum or urine pregnancy test within 14 days of the enrollment.
  7. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month (4 weeks) after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

  1. Patients who have been diagonised accelerated phase and blast crisis CML in previous therapy if only once.
  2. Patients with CCyR at the time of screening

  3. Any below impaired cardiac function:

    • LVEF <45% or < lower bound of normal limit of study site (whichever higher), confirmed by echocardiogram at the site
    • Patients who cannot have QT intervals measured according to ECG
    • Complete left bundle branch block
    • Patients with cardiac pacemakers
    • Patients with congenital long QT syndrome or the family history of known long QT syndrome
    • History of, or presence of symptomatic ventricular or atrial tachyarrhythmias
    • Clinically significant resting bradycardia (< 50 bpm)

    • The mean QTcF >450msec following three consecutive ECG tests at baseline

      : Screening test will be performed again for QTcF after the adjustment of electrolyte if QTcF >450msec and the electrolyte is not within the normal range.

    • Medical history of clinically confirmed myocardial infarction
    • Medical history of unstable angina (within last 12 months)
    • Other clinically significant cardiac disease
  4. Patients with T315I point mutations
  5. Patients with central nervous system involvement as cytopathologically confirmed
  6. Severe or uncontrolled chronic disease
  7. Significant medical history of congenital or acquired bleeding disorders that are not related to leukemia
  8. Patients who previously received radiotherapy to at least 25% of the bodies with high portion of bone marrow
  9. Patients who received the major surgery within 4 weeks before the initiation of the IP administration or who failed to recover from the surgery that was performed before then.
  10. Patients who participated in other clinical study and are receiving any other IP.
  11. Patients who cannot give consent to the clinical study.
  12. Patients who have concurrently clinically significant primary malignancy
  13. Patients currently receiving treatment with a strong CYP3A4 inhibitors or strong CYP3A4 inducers or therapeutic Cumarin derivatives and that can neither stop the administration of these drugs before the start of the IP administration nor switch to other drugs.
  14. Patients who are currently receiving treatment with a medication that has the potential to prolong QT intervals and can neither stop the administration of the drugs before the start of the IP administration nor switch to other drugs. If subjects need to start such drug treatments during the study, they should contact the sponsor, IL-YANG PHARM. Co., Ltd.
  15. Gastrointestinal disorder or gastrointestinal disease that may result in a significant change in the absorption of the investigational product
  16. Medical history of acute or chronic pancreatitis within the past one year
  17. Acute or chronic liver, pancreas, or severe kidney disease that are not associated with the disease
  18. Patients known seropositive to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, or cirrhosis. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL or site specific local lab normal range lower limit assessed by investigator), and cured hepatitis C patients can be enrolled.

  19. Women patients that meet the following conditions should be excluded from the clinical study.

    • Pregnancy
    • Breastfeeding
    • Pregnancy confirmed at screening pregnancy test
    • Women of childbearing potential who is unwilling to use an appropriate method of contraception during the study
  20. Men patients who are unwilling to use and appropriate method of contraception during the study
  21. Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Radotinib HCl

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.
Drug: Radotinib HCl
  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.
Other Names:
  • SUPECT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major Cytogenetic Response (MCyR)
Time Frame: at month 6
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.
at month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cytogenetic Response (CCyR)
Time Frame: at month 12/24, by month 24
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.
at month 12/24, by month 24
Major molecular response
Time Frame: at month 12/24, by month 24
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.
at month 12/24, by month 24
Overall Survival(OS)
Time Frame: by month 24
OS is defined as the duration from the first day of Radotinib administration to the day of death for certain causes.
by month 24
Progression Free Survival (PFS)
Time Frame: by month 24
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.
by month 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BCR-ABL1 point mutation
Time Frame: up to month 24
Incidence rate of BCR-ABL1 point mutations that are newly found during the course of radotinib treatment
up to month 24
correlation between the concentration of radotinib in blood and the response (efficacy and safety)
Time Frame: up to month 24
To measure the concentration of radotinib in blood
up to month 24
Incidence of Radotinib-Adverse Events
Time Frame: up to month 24
Toxicities will be evaluated in all subjects treated with radotinib.
up to month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Il-Yang Pharm. Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dong Wook Kim, the Catholic University of Korea's St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RT51KRI03
  • 2018-003810-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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