An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Progressing Or Recurring After One Prior Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Best Overall Response
研究概览
简要总结
The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.
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
- •Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented
- •Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion
- •Evidence of measurable disease by radiographic technique
- •Adequate organ function.
排除标准
- •Clinically relevant ascites (i.e. requiring paracentesis)
- •Severe weight loss
- •NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment
- •Diagnosis of second malignancy within last 3 years
- •History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- •Known HIV
- •Serious acute or chronic illness
- •Current treatment on another clinical trial
- •Pregnant or breastfeeding
研究组 & 干预措施
A
50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed
干预措施: Sunitinib (Drug)
结局指标
主要结局
Best Overall Response
时间窗: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Objective Response (Complete Response (CR) or Partial Response (PR))
时间窗: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
次要结局
- Time to Tumor Progression (TTP)(From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter)
- Progression-Free Survival(From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death)
- Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks(From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study)
- Duration of Response (CR or PR)(Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer)
- Overall Survival(From start of study treatment until death)