A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response)
研究概览
简要总结
The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied.
详细描述
The Study Drug:
Tesetaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 Groups based on when you enroll in this study. Each group has 2 "stages."
Group A:
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
- •At least 18 years of age.
- •Histologically confirmed diagnosis of melanoma.
- •Progressive disease that is not surgically resectable, or metastatic Stage IV disease.
- •Measurable disease.
- •Serum LDH </= 1.1 times the upper limit of normal (x ULN).
- •Eastern Cooperative Oncology Group performance status 0 or
- •Treatment with 1 prior regimen (including cytotoxic chemotherapy, immunotherapy, radiation therapy, or cytokine, biologic, or vaccine therapy) as first-line treatment for metastatic disease. (Administration of interleukin-2 or interferon as adjuvant therapy is allowed and is not to be considered in determining the 1 prior treatment regimen administered as first-line treatment for metastatic disease.)
- •Adequate bone marrow, hepatic, and renal function, as evidenced by: a) Absolute neutrophil count (ANC) >/= 1500/mm^3; b) Platelet count >/= 100,000/mm^3; c) Hemoglobin >/= 9 g/dL without need for hematopoietic growth factor or transfusion support; d) Aspartate aminotransferase (AST) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN; e) Alanine aminotransferase (ALT) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN f. Total bilirubin </= 1.5 x ULN;
- •(Continued # 8) g) Alkaline phosphatase </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN or, in the presence of bone metastasis, </= 10 x ULN; h) Serum creatinine </= 1.5 x ULN; i) Serum albumin >/= 3.0 g/dL; j) Prothrombin time (PT) </= 1.5 x ULN (or international normalized ratio [international normalized ratio (INR)] </=1.3); k) Partial thromboplastin time (PTT) </= 1.5 x ULN.
- •At least 3 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent.
- •Ability to swallow an oral solid-dosage form of medication.
- •A negative serum pregnancy test within 7 days prior to the first dose of study medication in women of childbearing potential (that is, all women except for those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization).
- •Agreement to use a highly effective form of contraception (ie, one that has a failure rate of < 1%) throughout the treatment phase of the study in women of childbearing potential (that is, all women excluding those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization) and sexually active men
- •Written informed consent and authorization to use and disclose health information.
- •Ability to comprehend and to comply with the requirements of the study.
排除标准
- •History or presence of brain metastasis or leptomeningeal disease.
- •Primary ocular or mucosal melanoma.
- •Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
- •Human immunodeficiency virus infection based on history of positive serology.
- •Significant medical disease other than cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
- •Organ allograft.
- •Presence of neuropathy > Grade
- •Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid.
- •Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy.
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity.
- •Less than 2 weeks since use of a medication or ingestion of an agent that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein.
- •Pregnancy or lactation.
研究组 & 干预措施
Tesetaxel
Therapy initiated at a flat dose of 40 mg for subjects in Cohort A and at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
干预措施: Tesetaxel (Drug)
结局指标
主要结局
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response)
时间窗: Day 84
Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to \< 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.
Number of Participants With Response
时间窗: Day 84
Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to \< 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.
次要结局
未报告次要终点