ACTRN12619000640101已完成2 期
A Phase 2, open label study of orally administered PAX-1 monotherapy in patients with recurrent glioblastoma.
ovotech (Australia) Pty Limited0 个研究点目标入组 40 人开始时间: 2019年4月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1.Patients with recurrent GBM (based on radiological or histological evidence of recurrence) who are resistant to SOC (radiation, second-line treatments including re surgery, or any other treatment deemed appropriate by the PI)
- •2.Male or female patients >18 years of age (or age of legal adult, whichever is older) and <70 years of age
- •3.Patients with an ECOG status 0-2
- •4.RANO criteria defined measurable disease as bidimensional contrast-enhancing lesions with clearly defined margins, with 2 perpendicular diameters of at least 10 mm by MRI imaging at baseline
- •5.Patients must have adequate haematological, hepatic and renal functions:
- •Absolute neutrophil count (ANC) = 1.5 x109/L
- •Platelet count = 100 x109/L
- •Haemoglobin = 90 g/L (> 9.0 g/dL)
- •Total bilirubin = 1.5 upper limit of normal (ULN) (< 2.5 ULN if patient has Gilbert’s syndrome)
- •AST/ALT = 2.5 x ULN; = 5 x ULN for patients with liver metastases
- •Serum creatinine within normal range or calculated creatinine clearance > 50 mL/min
- •Albumin = 33 g/L
- •International normalised ratio (INR) and activated partial thromboplastin time (APTT) < 1.5 ULN
- •Serum magnesium 0.70 to 1.10 mmol/L (magnesium replacement strategies may be used in case of deficiency)
- •Serum potassium = 3.5 mmol/L (potassium replacement strategies may be used in case of deficiency)
- •Serum electrolyte levels (e.g. calcium, phosphorus) within normal range or deemed not clinically significant by the Investigator.
- •6.The patient is able to take oral medication
- •7.Recovery from the effects of prior therapy, including minimum washout before enrolment in the study is as below:
- •4 weeks from non-nitrosoureas cytotoxic agents (3 weeks from procarbazine, 2 weeks from vincristine)
- •2 weeks from daily or metronomic chemotherapy (the patient must have recovered from the expected toxic effects of such therapy to their baseline or to grade 1)
- •6 weeks from nitrosoureas cytotoxic agents
- •4 weeks from any investigational agents
- •1 week from non-cytotoxic agents
- •12 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field
- •8.Women of childbearing potential (WOCBP) must have a negative serum beta- human chorionic gonadotrophin (HCG) pregnancy test documented within 7 days prior to IP initiation.
- •9.Women of childbearing potential and sexually active male patients must agree to use two reliable methods of contraception i.e., oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, intrauterine device (IUD), tubal ligation, or vasectomy of their sexual partner(s) for > 30 days before Screening and up to 90 days after discontinuation of study treatment
- •10.Male subjects with female partners of child-bearing potential must agree to meet 1 of the following contraception for > 30 days before Screening and up to 90 days after discontinuation of study treatment.
- •Documentation of successful vasectomy or azoospermia.
- •Male condom plus partner use of 1 of the contraceptive options listed above for contraception for WOCBP (oral contraceptives, hormonal injectable, transdermal, or implanted contraceptives, IUD, tubal ligation)
- •Male subjects must also agree not to donate sperm up to 90 days after discontinuation of study tr
排除标准
- •1.Presence of leptomeningeal disease
- •2.Patients with documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- •3.Active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barre syndrome). Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enrol
- •4.Female patients who have been pregnant within the 6 months prior to Screening or breastfeeding within the 3 months prior to Screening
- •5.Patients with ECG evidence of a QTcF > 450 ms in men and > 470 ms in women and patients with any other risk factors for torsade de pointes (TdP) (such as hypokalaemia, hypomagnesaemia or hypocalcaemia or family history of long QT syndrome)
- •6.Patients with uncontrolled cardiac disease (e.g. uncontrolled hypertension: diastolic blood pressure [DBP] >100 mmHg, or systolic blood pressure [SBP] >180 mmHg)
- •7.Myocardial infarction within 6 months before enrolment, unstable angina, New York Heart Association (NYHA) class III or greater congestive heart failure, history of uncontrolled seizures, oxygen dependent chronic diseases, and active psychiatric disorder
- •8.Stroke or transient ischaemic attack within 6 months before enrolment
- •9.Clinically significant chronic obstructive pulmonary disease or uncontrolled asthma
- •10.A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer or other solid tumours curatively treated with no evidence of disease for = 2 years
- •11.Patients with known or suspected to have hypersensitivities, allergies to sodium meta arsenite, related compounds or any of the excipients of the IP
- •12.Unresolved toxicity > Grade 2, using Common Terminology Criteria for Adverse Events (CTCAE), attributed to any prior therapies (excluding haemoglobin, alopecia, pigmentation, and chemotherapy-induced neurotoxicity)
- •13.Patients with use of doses of paracetamol in excess of 4 g/day over the 6 months prior to Screening, or with severe malnutrition which may lead to glutathione depletion
- •14.Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins or low-dose aspirin
- •15.Patients with an inability to comply with study procedures or any condition which in the Investigator's opinion makes the patient unsuitable for study participation
- •16.Patients with a psychiatric illness who the Investigator deems will have difficulty adhering to the study requirements
- •17.History of psychotic symptoms requiring antipsychotic treatment or history of a suicidal attempt/s within the prior 6 months
- •18.History or evidence of any other clinically significant condition including post-operative complications that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study procedures, evaluation or completion
- •19.Subjects with pseudoprogression will be excluded based upon imaging and the opinion from the Investigator.
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