NCT03508011已完成1 期
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
Impact Therapeutics, Inc.2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年8月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- The AEs (adverse event) of single and multiple doses of IMP4297 administered to participants with advanced solid tumors.
研究概览
简要总结
This is a Phase I, first-in-human, open-label, dose-escalation study of IMP4297 administered orally once every day to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Patients with advanced breast cancer, ovarian cancer or prostate cancer are preferred. There are two stages to this study: a dose-escalation stage and a dose-expansion stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •18 Years to 70 Years (including 18 and 75 years)
- •Histologically or cytologically documented disease; incurable, advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •In the dose expansion stage, patients with BRCA (breast carcinoma) mutation will be enrolled. Patients with breast cancer, ovarian cancer and prostate cancer are preferred.
- •In the dose escalation phase, at least one assessable lesion according to the RECIST 1.1 standard; In the dose expansion phase, at least one measurable lesion according to RECIST 1.1.
排除标准
- •Inadequate hematologic and organ function, defined by the following (hematologic parameters must be assessed ≥14 days after a prior treatment, if any):
- •Absolute neutrophil count <1500 cells/µL
- •Hemoglobin < 9 g/dL
- •Total bilirubin > 1.5 × the upper limit of normal (ULN), with documented liver metastases total bilirubin > 3 × the ULN.
- •Aspartate transaminase (AST) and/or alanine transaminase (ALT) > 2.5 × the ULN, with documented liver metastases AST and/or ALT levels > 5 × the ULN.
- •Serum creatinine > 1.5 × the ULN, or creatinine clearance < 45 mL/min based on a documented 24-hour urine collection or Cockcroft-Gault calculation of glomerular filtration rate.
- •International normalized ratio (INR) > 1.5 × the ULN or activated partial thromboplastin time (aPTT) > 1.5 × the ULN.
- •The INR applies only to patients who do not receive therapeutic anti-coagulation.
- •Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, radiotherapy within 4 weeks prior to initiation of study treatment with the following exceptions:
- •Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists for prostate cancer.
- •Hormone-replacement therapy or oral contraceptives.
- •Palliative radiation to bone metastases > 2 weeks prior to Day
- •Adverse events from prior anti-cancer therapy that have not resolved to NCI CTCAE Grade ≤ 1, except for alopecia.
- •Prior therapies targeting PARP (poly-ADP ribose polymerase).
- •Clinical significant active infection
- •Known clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Known human immunodeficiency virus infection
- •New York Heart Association Class II or greater congestive heart failure; history of myocardial infarction or unstable angina within 6 months prior to Day 1; history of stroke or transient ischemic attack within 6 months prior to Day 1
- •Active or untreated brain metastasis
- •Pregnant (positive pregnancy test) or lactating women
- •Male or female patients of child-producing potential unwilling to use double barrier contraception: condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (oral, injectable or parenteral), implanon, or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
- •Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
- •Inability to comply with study and follow-up procedures
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
研究组 & 干预措施
IMP4297
Experimental
干预措施: IMP4297 (Drug)
结局指标
主要结局
The AEs (adverse event) of single and multiple doses of IMP4297 administered to participants with advanced solid tumors.
时间窗: Each visit after IMP4297 administrated (through study completion, an average of 10 months)
Evaluate the TEAE (treatment-emergent adverse event) of IMP4297
The maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLTs) of IMP4297
时间窗: Within 28 days after IMP4297 administrated
Evaluate DLT and determine the MTD
次要结局
- Area Under Curve [AUClast, AUCINF](Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle))
- Maximum plasma concentration (Cmax)(Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle))
- Time at which Cmax occurred (Tmax)(Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle))
- Trough Concentrations (Ctrough)(Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle))
- Volume of distribution (Vd/F)(Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle))
- Clearance (CL/F)(Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle))
研究者
研究点 (2)
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