ACTRN12611000159954已完成1 期
A Phase I/II, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Diagnosis of PMF or post-ETIPV MF as per revised World Health Organization (WHO) criteria.
- •- High-risk or Intermediate-2 risk MF (as defined by the International Prognostic Scoring System [IPSS]); or intermediate-I risk MF (IPSS) associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy.
- •- Must be at least 18 years of age with life expectancy of >= 12 weeks.
- •- Must be able to provide informed consent and be willing to sign an informed consent form.
- •- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- •- Must have evidence of acceptable organ function within 7 days of initiating study drug as evidenced by the following:
- •-->SGOT (AST) or SGPT (ALT) <= 2.5 x upper limit of normal (ULN) (or <= 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis)
- •-->Bilirubin <= 2.0 x ULN or direct bilirubin < 1.0
- •-->Serum creatinine <= 2.5 x ULN
- •-->Absolute neutrophil count >= 500/microlitre
- •-->Platelet count >= 50,000/microlitre
- •- Females of childbearing potential must have a negative pregnancy test within 4 days of initiating study drug.
排除标准
- •- Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide), immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to initiation of study drug.
- •- Incomplete recovery from major surgery within four weeks of study entry.
- •- Radiation therapy within four weeks of study entry.
- •- Women of childbearing potential, unless surgically sterile for at least 3 months (i.e., hysterectomy), OR postmenopausal for at least 12 months (FSH > 30 U/mL), OR unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed.
- •- Men who partner with a woman of childbearing potential, unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through to the end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed.
- •- Females who are pregnant or are currently breastfeeding.
- •- Known positive status for HIV.
- •- Clinically active hepatitis B or C.
- •- Diagnosis of another malignancy unless free of disease for at least three years following therapy with curative intent. Patients with early-stage basal cell or squamous cell skin cancer, cervical intraepithelial neoplasia, cervical carcinoma in situ or superficial bladder cancer may be eligible to participate at the Investigator's discretion.
- •- Any acute active infection.
- •- Cardiac dysrhythmias requiring treatment, or prolongation of the QTc (Fridericia) interval to >450 msec for males or >470 msec for females at pre-study screening, unless attributable to pre-existing bundle branch block.
- •- Presence of >= Grade 2 peripheral neuropathy.
- •- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to initiation of study drug.
- •- Uncontrolled inter current illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
研究者
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