A Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 10
- 主要终点
- To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.
研究概览
简要总结
Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful.
This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.
详细描述
OUTLINE: This is a multi-center study.
This study will follow the 3+3 design with the following dose levels:
- Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2
Dose escalation starts from dose level 1.
Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle.
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
- •Histologically or cytologically confirmed advanced solid organ malignancy that is refractory to currently available therapies or for which no effective therapy exists.
- •Must have measurable or evaluable disease per RECIST as evaluated by imaging within 30 days prior to registration for protocol therapy.
- •Must have completed chemotherapy at least 28 days prior to registration for protocol therapy and recovered from the acute toxic effects.
- •Prior radiation therapy is allowed to < 25% of the bone marrow. Patients must have recovered from the acute toxic effects of radiation prior to registration for protocol therapy.
- •Must be willing to consent to the blood sample collection for SNP analysis.
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 30 days following completion of protocol therapy.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Age > 18 years.
排除标准
- •No prior therapy with cyclophosphamide or anthracyclines.
- •No treatment with any investigational agent within 28 days prior to registration for protocol therapy.
- •No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.
- •No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- •No symptomatic brain metastases. Patients with treated brain metastasis must be off steroids and must have completed radiation at least 21 days prior to registration for protocol therapy.
研究组 & 干预措施
1
Amrubicin + Cyclophosphamide 3+3 design with the following dose levels:
Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2
Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2
Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2
Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2
Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2
干预措施: Amrubicin (Drug)
1
Amrubicin + Cyclophosphamide 3+3 design with the following dose levels:
Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2
Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2
Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2
Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2
Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.
时间窗: 24 months
次要结局
- To assess response to the combination of amrubicin and cyclophosphamide(24 months)
- To determine the toxicities of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.(24 months)
研究者
Lawrence Einhorn
Sponsor-Investigator
Hoosier Cancer Research Network