NL-OMON32784已完成2 期
A phase I dose escalation, multi-center, open-label study of AUY922 administered IV on a once-weekly schedule in adult patients with advanced solid malignancies including phase II expansion arms in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. - AUY922 in solid tumors and HER2+ or ER+ Metastatic Breast Cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Breast cancer phase II expansion arms only
- •1a. Female patients with ER positive HER2 positive locally advanced non-operable metastatic breast cancer with history of trastuzumab resistance
- •1b. Female patients with ER positive non-operable locally advanced or metastatic breast
- •cancer who received endocrine therapy and whose disease has
- •progressed on at least one line of endocrine therapy for advanced disease.
- •2. At least one measurable lesion as defined by RECIST.
- •3. All patients must have progressive disease before entering to the study.
- •4. (WHO) Performance Status of * 2.
- •5. Life expectancy of * 12 weeks.
- •6. Patients must have the following laboratory values:
- •* Absolute Neutrophil Count (ANC) * 1.5 x 109/L
- •* Hemoglobin (Hgb) * 9 g/dl
- •* Platelets (plt) * 100 x 109/L
- •* Potassium, calcium, magnesium and phosphorus within normal limits or correctable with supplements
- •* Liverfunctiontests * 2.5 x Upper Limit of Normal (ULN) or * 5.0 x ULN if liver metastases are present
- •* bilirubin and creatinin * 1.5 x ULN or 24-hour clearance * 50 ml/min
- •* albumin * 2.5g/dl
排除标准
- •Main Exclusion criteria
- •1. CNS metastasis.
- •2. Prior treatment with any HSP90 or HDAC inhibitor compound.
- •3a. Radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks
- •3b. Nitrosoureas, mitomycin and monoclonal antibodies, such as trastuzumab: within 6 weeks
- •3c. Systemic anticancer treatment for which the recovery period
- •is not known, or investigational drugs within a duration of * 5 half lives of the agent and their active metabolites (if any)
- •4. Patients who have not recovered from side effects of previous systemic anticancer therapy to less than grade 2 prior to the first dose of study treatment
- •5. Treatment with therapeutic doses of sodium warfarin (Coumadin). Low doses of
- •Coumadin (e.g. * 2mg/day for line patency) are permitted.
- •6. Patients using medications that are substrates, inhibitors or inducers of CYP3A4,
- •CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued to an
- •alternative drug prior to commencing AUY922 dosing
- •7. Unresolved diarrhea * CTCAE grade 2.
- •8. Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline.
- •9. Acute or chronic liver disease.
- •10. Acute or chronic renal disease.
- •11. Other concurrent severe and/or uncontrolled medical conditions
- •12. Clinical significant cardiac disease e.g:
- •* History of long QT syndrome or Mean QTc * 450 msec
- •* History of clinically manifest ischemic heart disease * 6 months prior to
- •study start.
- •* History of heart failure or left ventricular (LV) dysfunction (LVEF * 45%) by MUGA
- •* Clinically significant ECG abnormalities
- •* History of atrial fibrillation, atrial flutter or ventricular arrhythmias
- •* Clinically significant resting bradycardia (< 50 beats per minute).
- •* Any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes
- •* Pacemaker.
- •13. Patients with known disorders due to a deficiency in bilirubin glucuronidation
- •14. Patients with a history of another primary malignancy that is currently clinically
- •significant or currently requires active intervention.
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