NCT01251640已完成1 期
A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 90
- 主要终点
- Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
研究概览
简要总结
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥18 years of age
- •Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
- •Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1
- •Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1
- •Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
- •Patient has cardiac function, within normal range, as measured by an echocardiogram
排除标准
- •Known history of, or symptomatic metastatic brain or meningeal tumors
- •History of cardiac disease
- •Active clinically serious infections
- •Clinically significant (ie. symptomatic) peripheral vascular disease
- •Pregnant or lactating women; women of childbearing potential not employing adequate contraception
- •Use of strong inhibitors or inducers of CYP3A4
- •Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy
- •Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment
- •Thrombotic or embolic events such within 6 months prior to start of study treatment
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY86-9766+Gemcitabine (Drug)
结局指标
主要结局
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
时间窗: From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
时间窗: From start of treatment until 134 weeks assessed every 8 weeks
次要结局
- Tumor Response: Investigator Assessment: Phase I(From start of treatment until 134 weeks assessed every 8 weeks)
- Disease Control (DC): Phase I(From start of treatment until 134 weeks assessed every 8 weeks)
- Duration of Response (DOR): Phase I(From start of treatment until 134 weeks assessed every 8 weeks)
- Disease Control (DC): Phase II(From start of treatment until 134 weeks assessed every 8 weeks)
- Time to Progression (TTP): Phase II(From start of treatment until 134 weeks assessed every 8 weeks)
- Progression-Free Survival (PFS): Phase II(From start of treatment until 134 weeks assessed every 8 weeks)
- Overall Survival (OS): Phase I(From start of treatment until 134 weeks assessed every 8 weeks)
- Overall Survival (OS): Phase II(From start of treatment until 134 weeks assessed every 8 weeks)
- Duration of Response: Phase II(From start of treatment until 134 weeks assessed every 8 weeks)
- Time to Progression (TTP): Phase I(From start of treatment until 134 weeks assessed every 8 weeks)
- Progression-Free Survival (PFS): Phase I(From start of treatment until 134 weeks assessed every 8 weeks)
研究者
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BAY 86-9766 in combination with gemcitabine in advanced pancreatic cancerPancreatic cancer is the eighth most common cause of cancer-related death worldwide, associated with a 5-year survival rate of 5-6%. A vast majority of patients present with incurable advanced disease. Untreated metastatic disease is associated with a median survival time of 3 to 5 months and locally advanced disease with 6-10 months.Gemcitabine is currently regarded as the standard therapy for locally advanced or metastatic pancreatic cancer.MedDRA version: 16.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864EUCTR2010-019588-12-BEBayer HealthCare AG93
进行中（未招募）
不适用
A multi-center, phase I/II study of BAY 86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer - NDon-resectable, locally advanced or metastatic Pancreatic CancerMedDRA version: 13.1Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-019588-12-ITBayer HealthCare AG90
进行中（未招募）
不适用
Study to investigate the novel drug BAY 86-9766 in combination with gemcitabine standard therapy in pancreatic cancer.Pancreatic cancer is the eighth most common cause of cancer-related death worldwide, associated with a 5-year survival rate of 5-6%. A vast majority of patients present with incurable advanced disease. Untreated metastatic disease is associated with a median survival time of 3 to 5 months and locally advanced disease with 6-10 months.Gemcitabine is currently regarded as the standard therapy for locally advanced or metastatic pancreatic cancer.MedDRA version: 16.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864EUCTR2010-019588-12-DEBayer HealthCare AG93