A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Progression Free Survival
研究概览
简要总结
A published phase 2 study reported that lonafarnib was administered as a single agent via continuous or intermittent oral dosing to 76 women with advanced breast cancer who were previously treated with chemotherapy and/or with endocrine therapy. Objective response rates of approximately 10% were observed. This study will determine the rate of progression-free survival of patients with metastatic breast cancer who receive lonafarnib.
详细描述
OUTLINE: This is a multi-center study
Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if encountered).
ECOG Performance Status 0-1
Life Expectancy: Not Specified
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
- •Histological or cytological confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
- •Must be able and willing to enroll in the companion study entitled "Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-03."
- •Must have measurable disease per RECIST as evaluated by imaging within 28 days prior to registration for protocol therapy.
- •Must be willing to not drink grapefruit juice for the duration of lonafarnib therapy.
- •Previously radiated area(s) must not be the only site of disease for study entry.
- •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 90 days following completion of study treatment.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Subjects 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.
- •Females must not be breastfeeding.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Age > 18 years
排除标准
- •No history or radiologic evidence of CNS metastases including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement (head CT or MRI must be obtained within 42 days prior to registration for protocol therapy).
- •No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- •No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or ventricular flutter.
- •No history of syncope.
- •No history of seizures.
- •No prolonged QTc interval > 450msec on pre-entry electrocardiogram obtained within 28 days prior to registration for protocol therapy.
- •No history of hypokalemia that cannot be corrected prior to registration for protocol therapy.
- •No radiation within 14 days prior to registration for protocol therapy. Patients must have recovered from the acute toxic effects prior to registration for protocol therapy.
- •No prior chemotherapy within 21 days prior to registration for protocol therapy.
- •No clinically active serious infections as judged by the treating investigator (CTC v3, > Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- •Following concomitant medications must be discontinued 7 days prior to registration for protocol therapy and for the duration of lonafarnib therapy: bisphosphonates, including but not limited to etidronate (Didronel), pamidronate (Aredia), alendronate (Fosamax), risedronate (Actonel), zoledronate (Zometa or Reclast), ibandronate (Boniva), ethinylestradiol, gestodene, itraconazole, ketoconazole, cimetidine, erythromycin, carbamazepine, high dose chronic steroids, phenobarbital, phenytoin, rifampin (rifampicin), sulfinpyrazone
研究组 & 干预措施
Lonafarnib
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
干预措施: Lonafarnib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 18 months
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.
次要结局
- Overall Response Rate(18 months)
- Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).(18 months)
- Toxicity Profile of Lonafarib(18 months)
研究者
George Sledge
Sponsor-Investigator
Hoosier Cancer Research Network