NCT00616213已完成1 期
A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors
Proacta, Incorporated6 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2008年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Maximum tolerated dose of PR-104
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors.
Secondary
- Characterize the safety of this regimen in these patients.
- Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.
- Evaluate the rate of hypoxia in various solid tumors using F-MISO PET (18F-fluoromisonidazole positron emission tomography) imaging.
- Assess for antitumor toxicity in these patients.
- Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed solid tumors
- •Measurable or evaluable disease
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status 0-1
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •PTT ≤ 1.5 times normal
- •Serum creatinine ≤ 1.5 times ULN
- •ALT or AST ≤ 2 times ULN (≤ 5 times ULN if liver metastases are present)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 30 days after completion of study therapy
- •Able to read, understand, and provide written informed consent
排除标准
- •Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:
- •Uncontrolled infection or infection requiring a concomitant parenteral antibiotic
- •Uncontrolled diabetes
- •Congestive heart failure
- •Myocardial infarction within the past 6 months
- •Chronic renal disease
- •Coagulopathy (excluding prophylactic anticoagulation)
- •Known HIV positivity
- •Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver function tests
- •PRIOR CONCURRENT THERAPY:
- •No more than 3 prior myelosuppressive chemotherapy regimens
- •Patients who have received more than 3 prior myelosuppressive regimens may be eligible, if considered to have adequate marrow, based on prior exposure to 1 of the following regimens:
- •Minimally myelosuppressive regimens
- •Limited courses of myelosuppressive regimens
- •More than 4 weeks since prior and no other concurrent licensed or investigational anticancer treatment (6 weeks for nitrosoureas or mitomycin C)
- •More than 24 hours since any prior radiotherapy and no likelihood of toxicity from this therapy
- •More than 4 weeks since major surgery
- •No prior radiotherapy to > 20% of bone marrow
- •No prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplantations)
- •Prior and concurrent androgen deprivation therapy allowed
- •Concurrent systemic steroids allowed, provided the patient has been on a stable dose for at least 2 weeks prior to first dose of PR-104
- •No concurrent irradiation therapy (palliative or therapeutic), unless given in the absence of tumor progression
结局指标
主要结局
Maximum tolerated dose of PR-104
时间窗: 3 weeks (cycle 1)
次要结局
- Pharmacokinetics of PR-104 and its alcohol metabolite in blood
- Anti-tumor activity
- Biomarkers of tumor hypoxia
- Dose-limiting toxicity of PR-104
- Safety profile using CTCAE v3 criteria
研究者
研究点 (6)
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