NCT00358566终止3 期
"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pharmexa A/S
- 入组人数
- 360
- 试验地点
- 86
- 主要终点
- Overall survival time
研究概览
简要总结
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.
详细描述
The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.
- •Adequate hematological parameters:
- •Hemoglobin >/= 9.5 g/dL [SI units, 5.9 mmol/L] WBC >/= 3000/mm3 [SI units, >/= 3 x 109/L] Platelets >/= 100,000/mm3 [SI units, >/= 100 x 109/L]
- •Adequate baseline liver function:
- •Total Bilirubin < 3x ULN and
- •Without liver metastases:
- •AST (SGOT) </= 2.5 x ULN ALT (SGPT) </= 2.5 x ULN
- •With liver metastases:
- •AST (SGOT) </= 5 x ULN ALT (SGPT) </= 5 x ULN
- •Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L].
- •Performance status ECOG 0-
- •Male or female 18 - 75 years inclusive.
- •Minimum life expectancy of 3 months.
- •Written informed consent.
排除标准
- •Treatment with chemotherapy for pancreatic cancer.
- •Treatment with other investigational drugs within the last 4 weeks prior to inclusion
- •Immune-suppressive therapy <4 weeks prior to inclusion
- •Chronic corticosteroid use except for asthma inhalers / topical use
- •Radiotherapy within 8 weeks of randomisation.
- •Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.
- •Known diagnosis of HIV (AIDS), Hepatitis B, C.
- •Known history of or co-existing autoimmune disease.
- •Known CNS metastases.
- •Clinically significant serious disease or organ system disease not currently controlled on present therapy.
- •Pregnancy or lactation.
- •Women of childbearing potential not using reliable and adequate contraceptive methods*
- •Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.
- •Unable for any other reason to comply with the protocol (treatment or assessments).
- •Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
研究组 & 干预措施
Gemcitabine
Active Comparator
Gemcitabine alone treatment.
干预措施: Gemcitabine (Chemotherapy) (Drug)
GV1001
Experimental
GV1001 in sequential combination with Gemcitabine
干预措施: GV1001 (Biological)
结局指标
主要结局
Overall survival time
时间窗: 12 month
次要结局
- Progression Free Survival(Time of progression)
研究者
研究点 (86)
Loading locations...
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