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A Phase 1/2 Multi-center, Open-label Study of Ponatinib in Japanese Patients With Chronic Myeloid Leukemia (CML) Who Have Failed Dasatinib or Nilotinib or Ph+ Acute Lymphoblastic Leukemia (ALL) Who Have Failed Prior Tyrosine Kinase Inhibitors (TKIs)

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Trial Profile

A Phase 1/2 Multi-center, Open-label Study of Ponatinib in Japanese Patients With Chronic Myeloid Leukemia (CML) Who Have Failed Dasatinib or Nilotinib or Ph+ Acute Lymphoblastic Leukemia (ALL) Who Have Failed Prior Tyrosine Kinase Inhibitors (TKIs)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 15 Jun 2022

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At a glance

  • Drugs Ponatinib (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors ARIAD Pharmaceuticals; Takeda Pharma

    • Most Recent Events

    • 29 Aug 2018 Status changed from active, no longer recruiting to completed.
    • 28 Sep 2016 According to an ARIAD Pharmaceuticals media release, Otsuka has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Iclusig (ponatinib) for the treatment of chronic myeloid leukemia (CML) resistant or intolerant to preceding drug treatment and relapsed or treatment resistant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), based on the data from this trial along with PACE trial and other Phase 1 trials.
    • 08 Jan 2016 Results published in the ARIAD Pharmaceuticals media release.

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