EUCTR2005-005543-25-MT进行中（未招募）不适用
Phase II Study of SKI-606 in Subjects with Advanced or Metastatic Breast Cancer
Wyeth Research Division0 个研究点目标入组 60 人开始时间: 2006年8月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Women > 18 years of age.
- •- Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV (as defined by the American Joint Committee on Cancer), not curable with available therapy.
- •- Relapsed or refractory after 1 to 3 prior chemotherapy regimens for advanced or metastatic disease.
- •- At least one measurable lesion, measuring > 20 mm.
- •- Karnofsky Performance Status of > 70%, and not declining within 4 weeks before first dose.
- •- Life expectancy of at least 16 weeks.
- •- Adequate hepatic, renal and bone marrow function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Chemotherapy, immunotherapy, surgery, hormone therapy, radiation therapy or any other anti-cancer therapy, within 2 weeks prior to dose day 1.
- •- Use of, or requirement for, bisphosphonates within 8 weeks prior to screening.
- •- Any other cancer within 5 years of screening (except basal cell carcinoma or cervical CIS)§Subjects with a history of prior stem cell transplant.
- •- Prior therapy with SKI-606 or any other Src kinase inhibitor.
- •- Extensive visceral disease as defined in the protocol
- •- Subjects with skin or bone as the only site of disease.
- •- Subjects with a history of CNS metastases will be eligible if the metastases have been treated with either RT or surgical resection and subjects are asymptomatic for three months, and no longer requiring steroids.
- •- An ongoing clinical requirement for administration of strong inhibitors of CYP-3A4.
- •- Needing frequent or continuous use of therapeutic doses of systemic steroids during the 6 months preceding screening.
- •- A left ventricular ejection fraction of less than 50% measured by multigated imaging of the heart (MUGA) or echocardiogram (ECHO).
- •- A History of clinically significant or uncontrolled cardiac disease including CHF (as defined by NY Heart Association 3 & 4), angina, MI, arrhythmia, prolonged QTc (>0.47 sec), or unexplained syncope.
- •- Concomitant use or need for medications known to prolong the QTc interval.
- •- A history of hypercalcemia within 2 weeks prior to screening.
- •- History of serum postassium > 5.5 mEq/L within 2 weeks prior to screening
- •- Uncorrected hypomagnesia or hypokalemia due to potential effects on the QT interval.
- •- Prior treatment with anthracyclines with a cumulative dose of > 400 mg/m2 of doxorubicin or equivalent.
- •- Subjects known to be HIV (human immunodeficiency virus) seropositive and/or acute or chronic hepatitis B (HbsAg positive) or C (anti-HCV positive).
- •- Pregnant or breastfeeding women or women of childbearing potential who are not using effective contraception.
- •- Recent (within 30 days of first dose) or ongoing clinically significant gastrointestinal disorder (e.g. malabsorption, short bowel syndrome, bleeding).
- •- Any other major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study.
研究者
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