NL-OMON36445招募中2 期
A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimen. - Phase Ib/II study of AUY922 plus trastuzumab in HER-2+ breastcancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 3
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
- •- Confirmed HER2-positive, non-operable locally advanced or metastatic breast cancer
- •- Tumor samples must demonstrate HER2 over-expression based on either:
- •- Immunohistochemistry (IHC) 3+ or IHC 2+ confirmed by fluorescence in-situ hybridization (FISH).
- •- At least 1 but no more than 2 prior anti-HER2 based regimens including at least 1 regimen containing Trastuzumab.
- •- At least one measurable lesion as defined by RECIST.
- •-ECOG Performance Status of <= 1
- •Patients must have the following laboratory values:
- •Absolute Neutrophil Count >=1.5x109/L
- •Hemoglobin >= 9 g/dl = 5.58 mmol/l
- •Platelets >=100x109/L
- •Potassium, total calcium and phosphorus within normal limits
- •Magnesium above LLN
- •Adequate liver function defined as:
- •AST/SGOT and ALT/SGPT <= 1.5 x Upper Limit of Normal or
- •AST/SGOT and ALT/SGPT <= 2.5 x Upper Limit of Normal (ULN) if <= 5.0 x ULN if liver metastases are present
- •Serum bilirubin <= 1.5 x ULN
- •Serum albumin > 2.5 g/dl
- •Serum creatinine <= 1.5 x ULN or 24-hour clearance >= 50 ml/min.
- •Negative serum pregnancy test.
排除标准
- •Patients with known CNS metastasis which are symptomatic or require treatment for symptom control and/or growing.
- •Prior treatment with any HSP90 or HDAC inhibitor.
- •Systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
- •- Palliative radiotherapy: within 2 weeks
- •- Nitrosoureas, mitomycin: within 6 weeks
- •Unresolved diarrhea >= CTCAE grade 1
- •Reversible side effects of previous systemic anticancer therapy (except for alopecia) to less than CTCAE grade 2 prior to the first dose.
- •Therapeutic doses of sodium warfarin (Coumadin).
- •Acute or chronic liver or renal disease.
- •Patients with other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.
- •Known hypersensitivity to any study medication.
- •Impaired cardiac function, including any one of the following:
- •- History (or family history) of long QT syndrome.
- •- Mean QTcF >= 450 msec on screening ECG.
- •- History of clinically manifested ischemic heart disease <= 6 months prior to study start.
- •- (LVEF <= 45%) by MUGA or ECHO.
- •- Clinically significant ECG abnormalities
- •- History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
- •- Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
- •- Clinically significant resting bradycardia (< 50 beats per minute).
- •- Current treatment with any medication which has a relative risk of prolonging the QTcF interval or inducing Torsades de Pointes
- •- Obligate use of a cardiac pacemaker.
- •Another primary malignancy that is currently clinically significant or currently requires active intervention.
研究者
相似试验
进行中（未招募）
不适用
A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimeEUCTR2009-015628-27-FRovartis Pharma Services AG52
进行中（未招募）
不适用
A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimeEUCTR2009-015628-27-SEovartis Pharma Services AG52
进行中（未招募）
1 期
A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimeEUCTR2009-015628-27-NLovartis Pharma Services AG45
进行中（未招募）
不适用
A clinical study to investigate the safety and efficacy of theinvestigational compound AUY922 when combined with trastuzumab inpatients with advanced HER2-positive breast cancer who haveprogressed on prior trastuzumab treatment.EUCTR2009-015628-27-DEovartis Pharma Services AG55
进行中（未招募）
1 期
A clinical study to investigate the safety and efficacy of the investigational compound AUY922 when combined with trastuzumab in patients with advanced HER2-positive breast cancer who have progressed on prior trastuzumab treatment.EUCTR2009-015628-27-GBovartis Pharma Services AG45