A Phase IA/IB Trial of PTX-200 and Carboplatin in Patients With Platinum-Resistant Recurrent Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.
详细描述
The purpose of this study is to investigate the safety and tolerability, and determine the maximum tolerated dose of triciribine when combined with carboplatin in women with platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to evaluate the clinical activity of carboplatin plus triciribine in women with recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate, progression-free survival, and duration of stable disease.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Histologically confirmed, measurable or non-measurable, recurrent or persistent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is defined by a disease-free interval of less than 6 months following treatment with a platinum-based regimen, or the progression of disease during platinum-based therapy.
- •At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
- •A serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry
- •Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000 mm^3; absolute neutrophil count ≥ 1500 mm^3; platelets ≥ 100,000 mm^3
- •Adequate hepatocellular function: aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤ 1.5 mg/dl
- •Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2
- •Life expectancy of at least 90 days
- •The patient should be off chemotherapy, biologic therapy and radiation for 28 days.
- •Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4
排除标准
- •Prior TCN-PM therapy
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to TCN-PM
- •Patients must be disease-free of prior invasive malignancies for >2 years with the exception of basal cell or squamous cell carcinoma of the skin.
- •Inability to give informed consent
- •Pregnancy
- •Corrected QT interval (QTc) prolongation > 450 milliseconds (msec)
研究组 & 干预措施
Triciribine & Carboplatin
Phase I/II: 25mg/m^2 Triciribine and Carboplatin AUC 4. Triciribine escalated to 30, 35, 45mg/m^2 if toxicities are not encountered.
Phase II: Recommended phase II dose of triciribine and carboplatin.
干预措施: Triciribine (Drug)
Triciribine & Carboplatin
Phase I/II: 25mg/m^2 Triciribine and Carboplatin AUC 4. Triciribine escalated to 30, 35, 45mg/m^2 if toxicities are not encountered.
Phase II: Recommended phase II dose of triciribine and carboplatin.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 6 months
To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).
次要结局
- Overall Response Rate (ORR)(2 years)
- Progression Free Survival (PFS)(2 years)
- Duration of Stable Disease (SD)(2 years)