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LeukemiaPhase 1/2NCT01602952

Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI

A Phase 1/2 study testing Radotinib in people with Leukemia and Leukemia, Myeloid, run by Il-Yang Pharm. Co., Ltd. at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase inhibitors (Imatinib and/ or Dasatinib, Nilotinib) In this study, The efficacy and safety of CML patients who are resistant or intolerable… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
12 sitesin 3 countries
Study dates
Jul 2008to 13 Jul 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Phase I
  • Age ≥ 18 years old
  • Ph+ CML patients who are resistant at chronic, accelerate, and acute phase, or suboptimal responsive, or intolerant to imatinib or resistant or intolerant to at least one second-generation targeted anticancer agent while being resistant, suboptimal responsive, or intolerant to imatinib simultaneously.
  • WHO Performance status of ≤2
  • Patients must have the following laboratory values With normal liver and renal function
  • Patients who have received interferon, other anti cancer drug or radiotherapy > 1 week prior to starting study drug.
Show all 12Show fewer
  • Phase II
  • Age ≥ 18 years old
  • Ph+ CML patients in chronic or accelerated phase who are resistant or intolerant to Imatinib mesylate
  • WHO Performance status of ≤2
  • Patients must have the following laboratory values With normal liver and renal function
  • Patients who have received interferon, other anti cancer drug or radiotherapy > 1 week prior to starting study drug.

Who cannot join

  • Phase I
  • CNS infiltration
  • Impaired cardiac function, including any one of the followings.
  • LVEF <45% as determined by MUGA scan or echocardiogram
  • Clinically significant resting bradycardia
  • Severe GI disease that may cause drug absorption problem of study drug
Show all 40Show fewer
  • Use of therapeutic Warfarin
  • Acute or chronic liver or renal disease
  • Other concurrent severe and/or uncontrolled medical conditions
  • Treatment with any hematopoietic colony-stimulating growth factors ≤1 week prior to starting study drug.
  • Patients who are currently receiving treatment with medications have the potential to prolong the QT interval
  • Patients who have received Imatinib, interferon, other anti cancer drug or chemotherapy ≤ 1 week
  • Patients who have received Nilotinib and Dasatinib ≤4 weeks prior to starting study drug.
  • Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who are pregnant or breast-feeding or adults of reproductive potential not employing an effective method of birth control.
  • Patients not to agree using birth control during the study and for up 3 months following study completion.
  • 15. HIV infection
  • Phase II
  • Blast phase CML
  • CNS infiltration
  • Impaired cardiac function, including any one of the following
  • LVEF< 45% as determined by MUGA scan or echocardiogram
  • Use of Cardiac pacemaker
  • ST depression > 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads
  • Congenital long QT syndrome
  • History of, or presence of significant ventricular or atrial tachyarrhythmias
  • Clinically significant resting bradycardia
  • QTcF> 480 msec on screening ECG
  • Right bundle branch block + left anterior hemiblock, Bifascicular block
  • Angina pectoris
  • Severe GI disease that may cause drug absorption problem of study
  • Use of therapeutic Warfarin
  • Acute or chronic liver or renal disease
  • Other concurrent severe and/or uncontrolled medical conditions
  • Treatment with any hematopoietic colony-stimulating growth factors ≤1 week prior to starting study drug.
  • Patients who are currently receiving treatment with medications have the potential to prolong the QT interval
  • Patients who have received Imatinib, interferon, other anti cancer drug or chemotherapy ≤ 1 week
  • Patients who have received wide field radiotherapy ≤4 weeks prior to starting study drug.
  • Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who are pregnant or breast-feeding or adults of reproductive potential not employing an effective method of birth control

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

South Korea9 sites

  • Local institution

    Anyang-si, Dongan-gu, 751-231

  • Local institution

    Busan, Seo-gu, 400-321

  • Local institution

    Daegu, Buk-gu, 511-230

  • Local institution

    Hwasun, Hwasun-eup, 322-511

  • Local institution

    Jeonju, Deokjin-gu, 212-789

  • Local institution

    Seoul, Jongro-ku, 231-855

  • Seoul St. Mary's hospital

    Seoul, Seocho-gu

  • Local institution

    Suwon, Yeongtong-gu, 781-512

  • Local institution

    Ulsan, Dong-gu, 411-978

Other trials in South Korea

India2 sites

  • Local institution

    Mumbai, Maharashtra, 741-234

  • Local institution

    Mumbai, Mazagaon, 512-364

Other trials in India

Thailand1 site

  • Local institution

    Bangkok, Phyathai, 215-714

Other trials in Thailand

About this study

Official title: A Phase I/II Multicenter Study of IY5511HCl in Philadelphia Chromosome Positive Chronic Myeloid Leukemia Patients Without Optimal Response or Tolerance to Bcr-Abl Tyrosine Kinase Inhibitors (Imatinib and/ or Dasatinib, Nilotinib)

A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase inhibitors (Imatinib and/ or Dasatinib, Nilotinib) In this study, The efficacy and safety of CML patients who are resistant or intolerable to imatinib in the Chronic and Accelerated phases.

Phase 1

Read more
  1. To investigate the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicity (DLT) of oral Radotinib HCl bid (twice daily) in the Philadelphia chromosome-positive CML subjects who are resistant, suboptimal responsive, or intolerant to imatinib OR resistant or intolerant to at least one second-generation targeted anticancer agent while being resistant, suboptimal responsive, or intolerant to imatinib simultaneously.

Phase 2

  1. To investigate safety of oral Radotinib HCl in CML patients who are resistant or intolerable to imatinib in the chronic and accelerated phases.
  2. To evaluate hematologic and cytogenetic efficacy of oral Radotinib HCl in CML patients who are resistant or intolerable to imatinib in the chronic and accelerated phases.
Read the detailed description

This study is a multi-center, open-label, Phase 1/2 clinical trial of Radotinib HCl, a targeted anticancer agent that inhibits the Bcr-Abl oncoprotein. It is aimed at determining the optimal therapeutic dose and confirming safety and efficacy of Radotinib HCl. Phase 1 study began at St. Mary's hospital in Korea and Phase 2 study is ongoing at 9 Korean sites and about 7 sites in China, India and Thailand will take part in Phase 2. After determination of a safe and proper therapeutic dose in Phase 1, Phase 2 began continuously to evaluate efficacy in chronic and accelerated phases. Before the start of the Phase 2 trial, interim or final reports for the Phase 1 trial were reviewed by the Korean Food and Drug Administration.

Being tested
Radotinib
Keywords
Radotinib, CML-CP, AP
Medical subject headings
Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadotinibDrug

    Also called IY5511HCl

    50mg, 100mg or 200mg Capsule BID

Study groups in NCT01602952
Study groupRoleWhat they receive
RadotinibExperimentalPhase 1 : 200mg/kg or 1200mg/m^2 Phase 2 : 400mg Bid
Receives: Drug: Radotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To investigate the Maximum Tolerated Dose(Phase 1)

    Radotinib will be given orally twice daily. Dose will be increased until it reaches MTD or the blood concentration of Radotinib stops rising

    Measured: 12 month

  2. Rate of Complete hematologic response(CHR)(Phase 2)

    Main parameters for response assessment in the chronic and accelerated phases include Major Hematologic Responses (MR; No Evidence of Leukemia or NEL + Complete Hematologic Response or CHR) lasting for 4 weeks and at least one major cytogenetic response (MCyR)

    Measured: 12 months

Secondary outcomes (4)

  1. To investigate the Dose Limiting Toxicity(Phase 1)

    The initial cohort will include 3 subjects who will receive 100mg Radotinib daily. If DLT is observed in one of the 3 subjects, the same dose will be given to 3 more subjects to evaluate safety.

    Measured: 12 months

  2. Rate of complete Cytogenetic Response(CCyR)(Phase 2)

    Cytogenetic response rate will be calculated as the percentage of Ph+ bone marrow metaphases as follows at least 20 bone marrow metaphases should be analyzed.

    Measured: 12 months

  3. Adverse events(Phase 1& Phase 2)

    All adverse events recorded during the study will be itemized and summarized. Severity, relation to the study medication, and seriousness will be summarized for each adverse event.

    Measured: 12 months

  4. Progression-free survival or PFS

    It is defined as the duration from the first day of administration to the earliest day of disease progression or death for certain causes. In subjects who have shown response, disease progression is defined as loss of MCyR.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2012 (estimated)
  2. Study startJul 2008
  3. Primary completionOct 2012
  4. Study completion13 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01602952
Sponsor's protocol ID
IY5511A1201
Status last verified
Aug 2018
First submitted
20 Apr 2012
Last updated
29 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Kim SH, Menon H, Jootar S, Saikia T, Kwak JY, Sohn SK, Park JS, Jeong SH, Kim HJ, Kim YK, Oh SJ, Kim H, Zang DY, Chung JS, Shin HJ, Do YR, Kim JA, Kim DY, Choi CW, Park S, Park HL, Lee GY, Cho DJ, Shin JS, Kim DW. Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL1 tyrosine kinase inhibitors. Haematologica. 2014 Jul;99(7):1191-6. doi: 10.3324/haematol.2013.096776. Epub 2014 Apr 4.

    PubMed 24705186

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radotinib in people with Leukemia and Leukemia, Myeloid, run by Il-Yang Pharm. Co., Ltd. at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea, India, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate the Maximum Tolerated Dose(Phase 1) (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01602952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.

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