A Phase I/II Trial of PTC299 in Patients With HIV-Related Kaposi's Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 8
- 主要终点
- Safety and Toxicity of Anti-VEGF Small Molecule PTC299
研究概览
简要总结
RATIONALE: PTC299 may stop the growth of Kaposi sarcoma by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of PTC299 and to see how well it works in treating patients with HIV-related Kaposi sarcoma.
详细描述
OBJECTIVES:
Primary
- To define the safety and toxicity of anti-VEGF small molecule PTC299 in patients with HIV-related Kaposi sarcoma.
- To establish the maximum tolerated dose of this drug in these patients.
- To estimate the response rate in patients treated with this drug.
Secondary
- To describe the pharmacokinetics of this drug in these patients.
- To describe the effects of this drug on serum and plasma VEGF, VEGFR, and cytokine profiles in these patients.
- To describe the effects of this drug on HIV and KSHV viral loads in these patients.
- To describe the effects of this drug on T-lymphocyte subsets (i.e., CD4 and CD8) in these patients.
- To describe the effects of this drug on VEGF, VEGFR-2 and -3, phospho-Akt, p53, and HIF-1α expression and tumor cell proliferation, as measured by Ki-67 staining, in tumor biopsy samples obtained from these patients.
- To describe the effects of this drug on viral gene expression and cellular gene transcription, as measured by real-time quantitative PCR-based profiling, in tumor biopsy samples obtained from these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: VEGF inhibitor PTC299 (Drug)
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: gene expression analysis (Genetic)
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: polymerase chain reaction (Genetic)
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: protein expression analysis (Genetic)
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: immunohistochemistry staining method (Other)
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: laboratory biomarker analysis (Other)
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: pharmacological study (Other)
VEGF Inhibitor PTC299
Single arm study - all subjects received PTC299
干预措施: biopsy (Procedure)
结局指标
主要结局
Safety and Toxicity of Anti-VEGF Small Molecule PTC299
时间窗: All study visits
Patients who experienced an adverse event of grade 3 or greater
Maximum Tolerated Dose
时间窗: After each group of 3 subjects completes cycle 1 of treatment
Response to Treatment
时间窗: After each 28-day cycle of treatment and at discontinuation of therapy
次要结局
- Pharmacokinetics(Days 1, 15, 28, 57)
- Effects of Study Drug on Serum and Plasma VEGF, VEGFR, and Cytokine Profiles(On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation)
- Effects of Study Drug on HIV and KSHV Viral Loads(Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation)
- Effects of Study Drug on T-lymphocyte Subsets (i.e., CD4 and CD8)(Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation)
- Effects of Study Drug on VEGF, VEGFR-2 and -3, Phospho-Akt, p53, and HIF-1α Expression and Tumor Cell Proliferation, as Measured by Ki-67 Staining, in Tumor Biopsy Samples(Screening and day 28)
- Effects of Study Drug on Viral Gene Expression and Cellular Gene Transcription, as Measured by Real-time Quantitative PCR-based Profiling, in Tumor Biopsy Samples(Screening and day 28)