NCT01098344已完成1 期
A Cancer Research UK Phase I Trial of an Oral Notch Inhibitor (MK-0752) in Combination With Gemcitabine in Patients With Stage III and IV Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Adverse event and severity according to NCI CTCAE Version 4.02
研究概览
简要总结
RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MK0752 together with gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving MK0752 together with gemcitabine hydrochloride and to see how well it works in treating patients with stage III or IV pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the recommended phase II dose of MK0752 in combination with gemcitabine hydrochloride in patients with unresectable stage III and IV pancreatic cancer. (Phase I)
Secondary
- To evaluate tumor response in patients treated with this regimen.
- To determine the time to disease progression and 6 months and 1-year survival.
- To determine the percentage of change in CA19-9 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas
- •Stage III and IV, unresectable disease
- •Assessable disease by endoscopic ultrasound or CT guidance
- •Tissue that is assessed by the Investigator as being accessible to biopsy - for patients recruited to dose escalation phase where three previous patients have not already provided biopsies
- •No known brain metastases
- •Patients with stable symptoms within the past 4 weeks, on a stable dose of steroids, and able to give informed consent are eligible
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 9.0 g/dL
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT ≤ 2.5 times ULN (≤ 5 times ULN if due to liver metastases)
- •PT ≤ 1.5 times ULN
- •Creatinine clearance ≥ 50 mL/min (uncorrected)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use two forms of highly effective contraception (females) 4 weeks prior to, during, and for 6 months after completion of study therapy or 1 form of highly effective contraception (males) during and for 6 months after completion of study therapy
- •Written (signed and dated) informed consent and capable of cooperating with treatment and follow-up
- •No nonmalignant systemic disease, including active uncontrolled infection, that confers a high medical risk to the patient
- •No known serologically positive HIV or hepatitis B or C infection
- •No other concurrent malignancies except adequately treated cone-biopsied carcinoma in situ of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease ≥ 5 years, and are deemed at negligible risk for recurrence
- •No concurrent congestive heart failure
- •No prior history of cardiac disease (New York Heart Association class III-IV disease), cardiac ischemia, or cardiac arrhythmia
- •No other condition that, in the investigator's opinion, would not make the patient a good recommendation for the clinical trial
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior treatments
- •Previous chemotherapy for advanced disease is permitted. If gemcitabine treatment was given previously, the patient must have tolerated a dose of at least 800mg/m
- •Previous chemotherapy for malignant disease must be complete at least 3 weeks before treatment on this trial (six weeks for mitomycin C)
- •No major thoracic or abdominal surgery from which the patient has not yet recovered
- •No concurrent participation or planned participation in another interventional clinical study
- •Concurrent participation in an observational study allowed
- •No concurrent warfarin
- •Low molecular weight heparin allowed
- •No concurrent radiotherapy (except palliative for bone pain), endocrine therapy, or immunotherapy
- •No other concurrent anticancer therapy or investigational drugs
排除标准
- 未提供
结局指标
主要结局
Adverse event and severity according to NCI CTCAE Version 4.02
Maximum-tolerated dose of MK0752 in combination with gemcitabine hydrochloride OR the single agent recommended Phase II dose in combination with either 800 mg/m² or 1000 mg/m² as agreed by DDO and clinicians
次要结局
- Plasma concentrations of MK0752
- Percentage change in CA19-9 levels
- Complete response, partial response, or stable disease as defined by RECIST criteria
- Progression-free survival
- Survival at 1 year
研究者
研究点 (5)
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