NCT01425879已完成2 期
A Multi-Institutional Phase II Study of the Akt Inhibitor MK-2206 in Refractory Biliary Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 8
- 主要终点
- Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1
研究概览
简要总结
This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the objective response rate (complete and partial response), as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, in patients with advanced refractory biliary cancers (BC) receiving Akt inhibitor MK2206 (MK2206).
SECONDARY OBJECTIVES:
I. To determine the frequency and severity of adverse events and tolerability of the regimen in patients with advanced refractory BC receiving MK2206.
II. To determine the overall and progression-free survival of patients with advanced refractory BC receiving MK2206.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed biliary tract carcinoma that is surgically unresectable
- •Cytological confirmation is not allowed on this study, as tissue is needed for correlative science analysis
- •Either fresh-frozen tissue (FFT) or paraffin-embedded tissue blocks (PETB) will be required from patients before enrolling on this study
- •No biopsies will be required unless there is insufficient tissue or if the PETB available is more than 12 months old
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with spiral CT scan (CT scan slice thickness no greater than 5 mm)
- •Malignant lymph nodes will be considered measurable if they are ≥ 15 mm in short axis
- •Patients must have received one prior therapy for metastatic disease
- •No prior Akt inhibitors allowed
- •Patients with known brain metastases should be excluded from this clinical trial
- •Life expectancy greater than 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) =<2 (Karnofsky >= 60%)
- •Leukocytes >= 3,000/mcL
- •Absolute neutrophil count (ANC) >= 1,500/mcL
- •Platelet count >= 100,000/mcL
- •Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT] =< 2.5 x IULN
- •Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (measured or calculated using the Cockroft-Gualt formula)
- •Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- •Not pregnant or nursing
- •Able to swallow oral tablets
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Akt Inhibitor MK2206 (MK2206) or other agents used in the study
- •Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
- •Cardiovascular: baseline QTcF > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study
- •Patients with clinically significant bundle branch block or pre-existing clinically significant bradycardia will be excluded from the study
- •No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements
- •No concurrent grapefruit or grapefruit juice
- •For patients having prior cryotherapy, radiofrequency ablation, ethanol injection, transarterial chemoembolization (TACE), or photodynamic therapy, the following criteria must be met:
- •6 weeks has elapsed since that therapy
- •Indicator lesion(s) is/are outside the area of prior treatment or, if the only indicator lesion is inside the prior treatment area, there must be clear evidence of disease progression associated with that lesion
- •Edges of the indicator lesion are clearly distinct on CT scanning
- •Prior radiation therapy with or without the use of a fluoropyrimidine as a radiosensitizer in the adjuvant setting will be allowed on study if > 12 weeks have elapsed since therapy
- •Prior palliative radiation therapy will allowed as long as > 4 weeks have elapsed since therapy
- •No patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Patients may not be receiving any other investigational agents
- •Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- •Patients receiving any medications or substances that are inhibitors or inducers of CYP 450 3A4 are ineligible
排除标准
- 未提供
研究组 & 干预措施
Treatment (Akt inhibitor MK2206)
Experimental
Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Akt Inhibitor MK2206 (Drug)
Treatment (Akt inhibitor MK2206)
Experimental
Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Diagnostic Laboratory Biomarker Analysis (Other)
Treatment (Akt inhibitor MK2206)
Experimental
Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1
时间窗: Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Overall Survival(From study initiation to time of death, assessed up to 4 weeks after completion of study treatment)
- Progression-free Survival(From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment)
- Frequency of Adverse Events Related to MK-2206(Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year)
研究者
研究点 (8)
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