NCT00459836已完成1 期
A Phase Ib, Multi-Center, Open-Label, Dose Escalation Trial of Intravenous PR-104 Given in Combination With Docetaxel or Gemcitabine in Subjects With Solid Tumors
Proacta, Incorporated5 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2007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
- 42
- 试验地点
- 5
- 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, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) 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 docetaxel or gemcitabine in treating patients with solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of PR-104 in combination with docetaxel or gemcitabine hydrochloride in patients with solid tumors.
Secondary
- Determine the safety of PR-104 in combination with docetaxel or gemcitabine hydrochloride in these patients.
- Determine the antitumor activity of these regimens using disease-specific parameters, such as exams, scans, and tumor markers, in these patients.
- Determine the pharmacokinetics of PR-104 and its alcohol metabolite in these patients.
- Determine the pharmacokinetics of docetaxel and gemcitabine hydrochloride when administered with PR-104.
- Collect plasma samples for assessment of potential biomarkers of tumor hypoxia from these patients.
- Examine metabolic changes in tumors using fludeoxyglucose F 18 positron emission tomography (PET) and PET imaging with fluoromisonidazole F 18 (a hypoxia-targeted radiopharmaceutical) in these patients.
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 confirmed solid tumor malignancy
- •Treatment with either docetaxel or gemcitabine hydrochloride in combination with an investigational agent is reasonable
- •Measurable or evaluable disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status of 0-1
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9.0 g/dL (red blood cell transfusion allowed)
- •Bilirubin normal
- •ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •PT/INR or aPTT ≤ 1.1 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 30 days after completion of study therapy
- •No evidence of any other significant medical disorder, including uncontrolled infection or infection requiring a concurrent parenteral antibiotic, or laboratory finding that, in the opinion of the investigator, would preclude study compliance
- •No known HIV positivity
- •No hepatitis B surface antigen positivity
- •No hepatitis C positivity with abnormal liver function test
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy to > 25% of bone marrow
- •No prior high-dose chemotherapy (including conditioning for either myeloablative or nonmyeloablative transplantation)
- •No more than 3 prior chemotherapy regimens
- •More than 4 weeks since prior major surgery
- •More than 4 weeks since prior investigational or traditional anticancer therapy (including radiotherapy) (6 weeks for nitrosoureas and mitomycin C)
- •The following medications/treatments are not permitted during the trial:
- •Any other licensed or investigational anticancer treatment
- •Prophylactic hematopoietic growth factors
- •Irradiation therapy (palliative or therapeutic) unless given in the absence of tumor progression
- •Concurrent systemic steroids allowed provided the patient is on a stable dose for ≥ 2 weeks prior to study treatment
- •Concurrent androgen-deprivation therapy allowed
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of PR-104
次要结局
- Safety of PR-104 as measured by CTCAE v3.0 criteria
- Dose-limiting toxicity of PR-104
- Pharmacokinetics of PR-104 and its alcohol metabolite in the blood
- Pharmacokinetics of gemcitabine and docetaxel in the presence of PR-104
- Antitumor activity
研究者
研究点 (5)
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