A Dose tolerability and Efficacy Study of RX-0201 plus Gemcitabine in Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- 1. Tolerability
研究概览
简要总结
This Study is an Open Lable, Single Arm dose tolerability and efficacy study od RX-0201 plus Gemcetabine in Metatatic Pancreatic Cancer. This study comprise of the Safety and the Efficacy phase. In the Safety phase, RX-0201 (250 mg/m2/Day) plus Gemcitabilne (1000 mg/m2) will be administered for 2 cycles as a combination therapy. In the Efficacy phase, RX-0201 (250 mg/m2/day) plus Gemcitabine (1000 mg/m2) will be administered for 4 cyclels as a combination therapy. The study will be conducted in 2 centers in US and 7 centers in India. The primary outcome of the study is Tolerability and Survival. The secondary outcome of the study is Response (assessed by RECIST), Molecular Markers (VEGF, AKT and CA 19-9) and Toxicity/Safety using CTCAE v. 3.0 (safety) and Vital Signs, ECG, Cllinical Laboratory Assessment (safety)Target Sample size for India- It will be basically be competitive recruitment & we at this point targeting to recruit 15 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who:
- •Provide written informed consent prior to the initiation of study procedures.
- •Are greater than 18 years of age
- •Have metastatic pancreatic cancer.
- •Have at least a measurable lesion by RECIST criteria.
- •Have a Karnofsky Performance Status of greater than
- •Have at least a 6-month life expectancy as assessed by the investigator.
- •Pre-menopausal women must be surgically sterile or agree to use an accepted method of birth control while participating in the study and for 30 days following the last exposure of study drug.
- •Acceptable forms of birth control are: hormonal contraceptives (oral, injectable, transdermal or implant), double-barrier contraceptives (condom or diaphragm with spermicide), and intrauterine device (IUD).
- •Male subjects need to either be surgically sterile or agree to use a barrier method of birth control described above during the study and for 30 days following the last exposure to study drug.
- •The agreed method of birth control by sunject will be discussed and documented in the source document of subject during the screening phase of the study.
排除标准
- •Subjects who:
- •Are unwilling or unable to provide informed consent.
- •Are unwilling or unable to comply with the requirements of the protocol.
- •Have been treated with another investigational agent.
- •Have any of the following screening laboratory values: i.
- •Hemoglobin less than 8.0 grams/deciliter (g/dL) ii.
- •Absolute neutrophil count (ANC) less than 1500/microliter iii.
- •Platelet count less than 100,000/microL iv.
- •Serum creatinine greater than 1.5 x the institutional upper limit of normal (IULN) creatinine.
- •Serum bilirubin greater than 1.5 X IULN vi.
- •Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) greater than 2 x IULN (greater than 5 x IULN in presence of known liver metastasis) vii.
- •Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) greater than 2 x IULN (greater than 5 x IULN in presence of known liver metastasis) viii.
- •Have a prothrombin time greater than 1.25 x IULN on screening laboratory assessments.
- •Lack Lewis antigens x.
- •HCV, and HBsAg positive Subjects xi.
- •CA 19-9 less than 75 U/ml
- •Have received either warfarin or heparin treatment within 21 days before Day 1 (the first day of dosing; except for line dose of prophylactic warfarin or heparin).
- •Have a history of an active hematologic malignancy within the past 2 years.
- •Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV).
- •Have a serious infection requiring intravenous antibiotic therapy during screening.
- •Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period.
结局指标
主要结局
1. Tolerability
时间窗: 1. At Every Cycle (14 day cycle). | 2. At 2,4 & 6 months from the last completed cycle.
2. Survival
时间窗: 1. At Every Cycle (14 day cycle). | 2. At 2,4 & 6 months from the last completed cycle.
次要结局
- Molecular Markers (VEGF, AKT and CA 19-9)(NIL)
- Response(Assessed by RECIST)(NIL)
- Toxicity/ Safety using CTCAE v. 3.0 (safety) and Vital Signs, ECG, Clinical Laboratory Assessment (Safety)(NIL)