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临床试验/EUCTR2014-001617-12-DE
EUCTR2014-001617-12-DE进行中（未招募）1 期

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses - OPTIC

Takeda Development Center Americas, Inc.0 个研究点目标入组 276 人开始时间: 2015年7月16日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
276
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Have CP-CML and have received at least two prior TKI therapies and have demonstrated resistance to treatment
  • •Have documented history of presence of T315I mutation after receiving any number of prior TKI.
  • •a. The diagnosis of CML will be made using standard hematopathologic and cytogenetic criteria; CP-CML will be defined by all of the following:
  • •i. < 15% blasts in bone marrow
  • •ii. < 30% blasts plus promyelocytes in bone marrow
  • •iii. < 20% basophils in peripheral blood
  • •iv. = 100 × 109/L platelets (= 100,000/mm3)
  • •v. No evidence of extramedullary disease except hepatosplenomegaly
  • •vi. No prior diagnosis of AP- or BP-CML
  • •b. Cytogenetic assessment at screening must demonstrate the BCR-ABL1 fusion by presence of the t(9;22) Philadelphia chromosome
  • •i. Variant translocations are only allowed provided they meet inclusion criterion 1d
  • •c. Resistance to prior TKI therapy is defined as follows (patients must meet at least 1 criterion):
  • •i. Three months after the initiation of prior TKI therapy: No cytogenetic response (> 95% Ph+) or failure to achieve CHR or new mutation
  • •ii. Six months after the initiation of prior TKI therapy: BCR-ABL1IS >10% and/or Ph+ >65% or new mutation
  • •iii. Twelve months after the initiation of prior TKI therapy: BCR-ABL1IS >10% and/or Ph+ >35% or new mutation.
  • •iv. At any time after the initiation of prior TKI therapy, the development of a new BCR-ABL1 kinase domain mutation(s).
  • •v. At any time after the initiation of prior TKI therapy, the development of new clonal evolution
  • •vi. At any time after the initiation of prior TKI therapy, the loss of CHR, or CCyR, or the confirmed loss of MMR in 2 consecutive tests, one of which has a BCR-ABL1IS transcript level of =1% or new mutation
  • •d. > 1% of BCR-ABL1IS as shown by real-time polymerase chain reaction
  • •2. Age = 18 years old.
  • •3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • •4. Have adequate renal function as defined by the following criterion:
  • •a. Serum creatinine = 1.5 × upper limit of normal (ULN) for institution
  • •b. Estimated creatinine clearance = 30 mL/min (Cockcroft-Gault formula)
  • •5. Have adequate hepatic function as defined by the following criteria:
  • •a. Total serum bilirubin = 1.5 × ULN, unless due to Gilbert's syndrome
  • •b. Alanine aminotransferase (ALT) = 2.5 × ULN, or = 5 × ULN if leukemic infiltration of the liver is present
  • •c. Aspartate aminotransferase (AST) = 2.5 × ULN, or = 5 × ULN if leukemic infiltration of the liver is present
  • •6. Have normal pancreatic status as defined by the following criterion:
  • •a. Serum lipase and amylase = 1.5 × ULN
  • •7. Have normal QT interval corrected (Frederica) (QTcF) interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of = 450 ms in males or = 470 ms in females.
  • •8. Have a negative pregnancy test documented prior to enrollment (for females of childbearing potential).
  • •9. Agree to use a highly effective form of contraception with sexual partners from randomization through at least 4 months after the end of treatment (for female and male patients who are fertile).
  • •10. Provide written informed consent.
  • •11. Be willing and able to comply with scheduled visits and study procedures.
  • •12. Have recovered from toxicities related to prior anticancer therapy to NCI CTCAE v 4.0 grade =1.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 202
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects

排除标准

  • •1. Have used any approved TKIs or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is longer, prior to receiving study drug.
  • •2. Received interferon, cytarabine or immunotherapy within 14 days; or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) from AEs (except alopecia) due to agents previously administered.
  • •3. Have undergone autologous or allogeneic stem cell transplant (SCT) < 60 days prior to receiving the first dose of ponatinib; have any evidence of ongoing graft versus-host disease (GVHD) or GVHD requiring immunosuppressive therapy.
  • •4. Are being considered for hematopoietic SCT (HSCT) within 6-12 months of enrollment (note: ponatinib is not to be used as a bridge to HSCT in this trial).
  • •5. Are taking medications with a known risk of Torsades de Pointes.
  • •6. Have previously been treated with ponatinib.
  • •7. Have active central nervous system (CNS) disease as evidenced by cytology or pathology; in the absence of clinical CNS disease, lumbar puncture is not required. History itself of CNS involvement is not exclusionary if CNS has been cleared with a documented negative lumbar puncture.
  • •8. Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
  • •a. Any history of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (TIA)
  • •b. Any history of peripheral vascular infarction, including visceral infarction
  • •c. Any revascularization procedure, including the placement of a stent
  • •d. Congestive heart failure (CHF) (New York Heart Association [NYHA] class III or IV) within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment
  • •e. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia
  • •f. Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrollment
  • •9. Have uncontrolled hypertension (i.e., >150 and >90 for SBP and DBP, respectively). Patients with hypertension should be under treatment at study entry to ensure blood pressure control. Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.
  • •10. Have poorly controlled diabetes defined as HbA1c values of > 7.5%. Patients with preexisting, well-controlled, diabetes are not excluded.
  • •11. Have a significant bleeding disorder unrelated to CML.
  • •12. Have a history of alcohol abuse.
  • •13. Have a history of either acute pancreatitis within 1 year of study enrollment or of chronic pancreatitis.
  • •14. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drug.
  • •15. Have a history of another malignancy, other than cervical cancer in situ or basal cell or squamous cell carcinoma of the skin; the exception is if patients have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
  • •16. Are pregnant or lactating.
  • •17. Have undergone major surgery (with the exception of minor surgical procedures, such as catheter placement or BM biopsy) within 14 days

研究者

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