An Open Label, Phase I, Single Group Assignment Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TTP607 Administered in Cycles of Five Daily One to Four Hour Infusions to Patients With Advanced Refractory Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of TTP607 that can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be studied.
Researchers will also do pharmacokinetic (PK) testing of TTP607. PK testing measures the amount of a drug in the body at different time points.
详细描述
The Study Drug:
TTP607 is designed to work by blocking the action of certain enzymes (proteins) in the blood that are responsible for abnormal growth of cancer cells. This may cause the cancer cells to eventually die.
Dose Level Assignment:
If you are found to be eligible to take part in this study, you will be enrolled in a group of 3-6 participants. The dose you receive will be based on when you join this study (on how many participants have been enrolled before you, and on the safety data that is available at that time). The first group of participants will receive the lowest dose of TTP607. Each new group of participants will receive the next highest dose of the study drug, as long as no intolerable side effects occur. This process will continue until the highest tolerable dose of TTP607 is reached. Once the highest tolerable dose is found, 12 additional participants will be enrolled and treated at that dose, so that researchers can learn more about the effects of the study drug on the tumor. Both you and your study doctor will know what dose of the study drug you are receiving.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which there is no standard therapy.
- •Measurable disease at baseline.
- •At least four weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agents, six weeks if the last regimen included BCNU or mitomycin C, six weeks if the agent was an antibody, four weeks if a chimeric antibody. For targeted therapies such as Gleevec®, Tarceva®, Nexavar®, Iressa®, or Sutent® at least five half-lives need to have elapsed since the last dose. Patients must be recovered from the adverse effects of prior therapy at the time of enrollment.
- •Age >/=18 years, male or female patients.
- •Women of child-bearing potential or men whose sexual partners are women of child-bearing potential must agree to use two methods of adequate contraception (i.e., hormonal and barrier method of birth control) prior to study entry, for the duration of the study, and for 30 days after the last dose of study medication.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or
- •Patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcL; absolute neutrophil count >/=1,500/mcL; platelets >/= 100,000/mcL; total bilirubin </= 2.0 mg/dL; AST(SGOT)/ALT(SGPT) </= 2.5 x upper limit of normal; and creatinine </= 2.0 mg/dL
- •Patients must have an existing patent and viable central venous catheter, or have such a line inserted within 28 days prior to initiation of study drug.
- •Patients must be able to understand and willing to sign a written informed consent document and have the capacity to follow study instructions.
排除标准
- •Uncontrolled concurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, life-threatening cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results. Patients with a history of myocardial infarction in the last three months are also excluded from the trial.
- •Patients with known brain metastases that are symptomatic
- •Patients with leukemias or myelodysplastic syndrome (MDS).
- •Patients who have undergone bone marrow or stem cell transplantation within the last 5 years.
- •A requirement, as judged by the Principal Investigator, for primary prophylaxis with colony stimulating factors based on an expectation by the investigator of a risk of febrile neutropenia of 20% or greater or clinical factors that predispose the patient to increased complications from prolonged neutropenia as discussed in the latest American Society of Clinical Oncology (ASCO) recommendations for the use of white blood cell growth factor guidelines.
- •Nursing or pregnant women.
- •Documented HIV, HBV or HCV infection.
- •Patients with hypersensitivity to compounds of similar chemical or biologic composition to TTP607 or constituents of the intravenous (i.v.) formulation.
研究组 & 干预措施
TTP607
干预措施: TTP607 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: End of each 15 day cycle
次要结局
未报告次要终点