NCT02730481已完成1 期
A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Activity of Oraxol in Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD) of Oraxol
研究概览
简要总结
This is a multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •≥18 years of age
- •Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- •Measurable disease as per RECIST v1.1 criteria
- •Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: ANC ≥1500 cells/mm3, Platelet count ≥100 x 109/L, Hemoglobin ≥9 g/dL
- •Adequate liver function as demonstrated by:Total bilirubin of ≤1.5 mg/dL or ≤2.0 mg/dL for subjects with liver metastasis, Alanine aminotransferase ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present, Alkaline phosphatase ≤3 x ULN or ≤5 x ULN if bone or liver metastasis is present
- •Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN or creatinine clearance calculation ≥60 mL/min as calculated by the Cockcroft and Gault formula
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Life expectancy of at least 3 months
- •Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug.
- •Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
排除标准
- •Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
- •Received IPs within 30 days or 5 half lives of the first study dosing day
- •Are currently receiving other medications or radiation intended for the treatment of their malignancy
- •Women of childbearing potential who are pregnant or breastfeeding
- •Currently taking a concomitant medication
- •Require therapeutic use of anticoagulation medications
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
- •Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption
- •History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity type reaction to Cremophor
研究组 & 干预措施
ORAXOL
Experimental
Oraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules
Oraxol HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets
干预措施: Oraxol (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of Oraxol
时间窗: 20 weeks
The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment
次要结局
- The amount of Oraxol in the blood stream(3 weeks)
- The recommended Phase 2 dose of paclitaxel as Oraxol(24 months)
- Evaluate tumor response(At baseline and every 8 weeks through study completion, approximately 24 months)
- Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment(4 weeks)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast CancerLocally Recurrent and Metastatic Breast CancerNCT00322400Amgen46
已完成
1 期
Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced MalignanciesSolid TumorNCT03987685Athenex, Inc.10
已完成
1 期
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung CancerBreast Cancer, Non-small Lung CancerNCT01862081Genentech, Inc.80
已完成
1 期
SKB410 for Injection in Solid TumorsAdvanced Solid TumorsNCT05906537Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.38
招募中
1 期
A Study of SKB315 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05367635Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.246