NCT01956812终止3 期
An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 334
- 试验地点
- 63
- 主要终点
- overall survival
研究概览
简要总结
The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Metastatic disease
- •Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
- •At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
- •Completed at least one cycle of the treatment
- •Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
- •Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
- •Progression was documented,
- •Preferentially radiologically by tumor growth or new lesions, or by
- •Clear symptomatic deterioration supported by at least two of the following clinical criteria: ≥ 10% worsening in KPS or ≥ 1 worsening in ECOG; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression.
- •KPS >/= 70
- •Adequate bone marrow function
- •Adequate hepatic function
- •Adequate renal function
排除标准
- •CNS metastatic disease
- •Bulky disease (any single mass >10 cm).
- •>Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.
- •Prior external beam irradiation to a field that includes more than 30% of the red bone marrow.
- •Patients with clinically significant severe cardiorespiratory disease.
- •Please consult with the clinical trial site for the full detailed list of specific inclusion/exclusion criteria.
研究组 & 干预措施
Arm A IMMU-107 and gemcitabine
Experimental
IMMU-107 and low dose gemcitabine
干预措施: IMMU-107 (Drug)
Arm A IMMU-107 and gemcitabine
Experimental
IMMU-107 and low dose gemcitabine
干预措施: Gemcitabine (Drug)
Arm B Placebo and low dose gemcitabine
Active Comparator
Placebo and low dose gemcitabine
干预措施: placebo (Drug)
Arm B Placebo and low dose gemcitabine
Active Comparator
Placebo and low dose gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
overall survival
时间窗: 24 months
次要结局
- Objective tumor response(24 months)
- Clinical benefit(24 months)
- Overall survival(3, 6 and 12 months)
- Progression free survival(24 months)
研究者
研究点 (63)
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