NCT01085214已完成2 期
A Phase 2 Study of AZD6244 in Multiple Myeloma
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
- 37
- 试验地点
- 9
- 主要终点
- Overall Response Rate
研究概览
简要总结
This phase II trial studies how well selumetinib works in treating patients with multiple myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop the growth of cancer cells by blocking this protein.
详细描述
PRIMARY OBJECTIVES:
I. To assess the response rate of AZD6244 (selumetinib) hydrogen sulfate capsules in patients with relapsed or refractory multiple myeloma (MM).
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of AZD6244 in patients with MM. II. To estimate progression-free survival and duration of response to AZD6244. III. To test whether AZD6244 hydrogen sulfate capsules downregulate tumor cell phosphorylated mitogen-activated protein kinase (pERK)1/2.
OUTLINE:
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
- •Confirmed diagnosis of multiple myeloma with relapsed or refractory disease following at least two prior therapies
- •Measurable disease defined as:
- •Serum monoclonal protein >= 1 gm/dL or
- •Urine monoclonal protein of >= 200 mg/24 hours, or
- •Measurable free light chains by free light chain assay of >= 10 mg/dL with abnormal kappa to lambda free light chain ratio, or
- •Measurable bone disease, defined as >= 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm with conventional techniques or >= 10 mm with spiral computed tomography (CT) scan (for patients with lytic bone disease)
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Absolute neutrophil count: >= 1,000/μL (independent of blood cell growth factors)
- •Platelets: >= 75,000/μL (independent of blood cell growth factors or transfusion)
- •Total bilirubin: =< 1.5 x upper normal limit; however, patients with documented Gilbert's syndrome are eligible
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]): < 2.5 x upper limit of normal (ULN)
- •Creatinine: < 3.0 x ULN
- •Known human immunodeficiency virus (HIV) infected patients meeting the following characteristics are eligible:
- •Cluster of differentiation (CD)4 cell count >= 500/mm^3
- •Meeting either of the following:
- •Willing to suspend antiretroviral therapy for duration of protocol therapy or
- •On stable regimen of combination antiretroviral therapy that does not include either zidovudine or stavudine for at least 12 weeks and without evidence of toxicity
- •No HIV-associated condition that defines acquired immunodeficiency syndrome (AIDS)
- •Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met:
- •>= 6 months have elapsed since allogeneic transplant
- •No graft vs. host disease (GVHD) is present
- •Not currently on immunosuppressive therapy
- •Women of child-bearing potential must agree to use a medically accepted form of contraception prior to, during, and for four weeks following study treatment; men must agree to use a medically accepted form of contraception prior to, during, and for sixteen weeks following study treatment
- •Able and willing to provide a written informed consent
- •Prior palliative and/or localized radiation therapy is permitted, provided at least 14 days have passed from date of last radiation therapy
- •Pulse oximetry of >= 95% on room air
排除标准
- •Any concurrent condition or planned treatment that would compromise study objectives or represent an unacceptable patient risk, including but not limited to:
- •Planned concurrent treatment for multiple myeloma other than bisphosphonates; ongoing corticosteroids for indications other than multiple myeloma allowed as long as the dose does not exceed 60 mg of prednisone per day or equivalent
- •Persisting effects of any previous or ongoing treatment that might compromise delivery of study treatment or assessment of adverse events
- •Planned concurrent treatment with any other investigational agents
- •Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration
- •No other malignancy unless the patient has been disease-free for >= 1 year
- •Known multiple myeloma of central nervous system or leptomeninges
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244
- •Previous mitogen activated protein kinase (MEK) inhibitor use
- •Uncontrolled hypertension, i.e., persistent blood pressure (BP) of >= 160/95
- •Significant cardiovascular disease (New York Heart Association class II, III or IV cardiac disease), hypertrophic cardiomegaly or restrictive cardiomyopathy, myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia unstable or a need for anti-arrhythmic therapy (use of medication for atrial fibrillation is allowed, if stable for at least 3 months)
- •Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or nursing
- •Left ventricular ejection fraction (LVEF) =< 45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan
- •Any requirement for supplemental oxygen
研究组 & 干预措施
AZD6244 (Selumetinib) Treatment
Experimental
Participants receive AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
AZD6244 (Selumetinib) Treatment
Experimental
Participants receive AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Selumetinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 2 years
Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).
次要结局
- Progression Free Survival (PFS)(From registration to progression or death, assessed up to 2 years)
- Incidence of Toxicity That May Be Treatment Emergent(1 year, 11 months)
- Duration of Response(From response to disease progression or death, assessed up to 2 years)
研究者
研究点 (9)
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