EUCTR2016-001754-18-RO进行中（未招募）1 期
A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Sun Pharma Advanced Research Company (SPARC) Limited0 个研究点目标入组 255 人开始时间: 2022年3月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 255
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.Willing and able to give written/signed, and dated, informed consent (or by legally acceptable representative/impartial witness when applicable - inclusion of subjects needing legally acceptable representative/impartial witness will be in compliance to the enrolling country’s regulatory requirement) and is available for the entire study
- •2.Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions and be accessible for follow-up
- •3.Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, or Ph+ ALL who are refractory or intolerant to at least 3 TKIs or are not eligible (e.g.: due to comorbidities, hypersensitivity to excipients, lack of insurance coverage) for their local country’s regulatory approved and medically appropriate TKIs (e.g.: a TKI that is effective against mutations in the patient’s tumor)
- •4.Male or female aged = 18 years
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •6.Adequate organ and immune system function as indicated by the laboratory values obtained = 2 weeks prior to IMP administration
- •7.Subjects of childbearing potential must practice a medically acceptable method of birth control as judged by the Investigator (refer to protocol for details)
- •8.Male subjects enrolled in the study should not father a child and are advised to prevent passage of semen to their sexual partner during intercourse using an acceptable method as detailed in the Inclusion criteria # 7 and judged by the Investigator for the duration of the study and for 3 months after the last IMP administration
- •9.Female subjects of childbearing potential must have a negative pregnancy test (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin).
- •10.Female subjects must be non-lactating and non-breast-feeding
- •1.Willing and able to give written/signed, and dated, informed consent (or by legally acceptable representative/impartial witness when applicable- inclusion of subjects needing legally acceptable representative/impartial witness will be in compliance to the enrolling country’s regulatory requirement) and is available for the entire study
- •2.Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions, and be accessible for follow-up
- •3.Subjects with Ph+CML CP, AP or BP who are resistant and/or intolerant to = 3 prior TKIs one of which includes ponatinib. (Subjects with Ph+ ALL are not included)
- •4.Male or female aged = 18 years
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •6.Adequate organ and immune system function as indicated by the following laboratory values obtained = 2 weeks prior to IMP administration.
- •7.Subjects of childbearing potential must practice a medically acceptable method of birth control as judged by the Investigator (refer to protocol for details)
- •8.Male subjects enrolled in the study should not father a child and are advised to prevent passage of semen to their sexual partner during intercourse using an acceptable method as detailed in the Inclusion criteria # 7 and judged by the Investigator for the duration of the study and for 3 months after the last IMP administration
- •9.Female subjects of childbearing potential must have a negative pregnancy test (as confirmed by a negative urine pregnancy test with a sensitivity of less than
排除标准
- •1.Presence of T315I mutations
- •2.Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
- •3.Inability to swallow oral medication
- •4.Inability to undergo venipuncture and/or tolerate venous access
- •5.Evidence of clinically significant organ dysfunction or any clinically relevant deviation from normal in physical examination, ECG findings, vital signs, or clinical laboratory test findings as per the Investigator’s discretion
- •6.Positive tests: urine pregnancy tests (if applicable), HIV
- •7.History of any relevant allergy/hypersensitivity (including known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the IMP or its excipients)
- •8.Known history of active hepatitis B or hepatitis C
- •9.Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer, of IMP administration
- •10.Use of concomitant medication that might influence the results of the study prior to IMP administration and/or anticipated need at any time during the study
- •11.Known or suspected history of significant drug abuse as judged by the Investigator
- •12.Known or suspected history of alcohol abuse or excessive intake of alcohol in the 12 months prior to study entry
- •14.Radiotherapy or cytotoxic chemotherapy within 21 days or Vincristine within 7 days (for Ph+ ALL only); interferon or Cytarabine or immunotherapy within 14 days prior to the first IMP administration visit
- •15.Malabsorption syndrome or other illness that could affect oral absorption of the IMP
- •16.Clinically significant, uncontrolled, or active cardiovascular disease
- •17.Uncontrolled intercurrent illness
- •18.Subjects eligible and willing to undergo transplant
- •20.Autologous or allogeneic stem cell transplant = 3 months prior to Screening
- •Other criteria may apply (refer to protocol)
- •1.Presence of T315I mutations
- •2.Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
- •3.Inability to swallow oral medication
- •5.Evidence of clinically significant organ dysfunction or any clinically relevant deviation from normal in physical examination, ECG findings, vital signs, or clinical laboratory test findings which in the opinion of the investigator may jeopardize the safety of the patient during the study or may interfere with the evaluation of the study medication.
- •6.Positive tests: urine pregnancy tests (if applicable), HIV
- •7.History of any relevant allergy/hypersensitivity (including known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the IMP or its excipients)
- •8.Known history of active hepatitis B or hepatitis C
- •9.Received an investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
- •10.Use of concomitant medication that might influence the results of the study prior to IMP administration/or anticipated need any time during the study
- •11.Known or suspected history of alcohol abuse or excessive intake of alcohol in the 12 months prior to study entry
- •12.Known or suspected history of significant drug abuse as judged by the Investigator
- •14.Radiotherapy or cytotoxic chemotherapy within 21 days or Vincristine within 7 days (for Ph+ ALL only); interferon or Cytarabine or immunotherapy within 14 days prior to the first IMP administration visit
- •15.Active central nervous system (CNS) disease as evidenced by cytology or pathology.
- •16.Malabsorption synd
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