EUCTR2006-002766-20-NL进行中（未招募）1 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. - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •1. Dose-escalation and MTD dose expansion arm: Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists.
- •Breast cancer phase II expansion arms only
- •a. Females patients with HER2 positive inoperable locally advanced or
- •metastatic breast cancer must have:
- •History of trastuzumab resistance, defined as either local or systemic disease
- •progression on treatment with at least 8 weeks of a trastuzumab containing regimen.
- •Received up to 3 prior anti HER2 based regimens (ie trastuzumab and/or lapatinib in combination with other agents) for advanced disease.
- •Received up to 2 lines of cytotoxic therapy for advanced disease
- •Patients who develop metastases while receiving adjuvant or neo-adjuvant trastuzumab are eligible.
- •HER2 positive patients, tumor/s must demonstrate HER2 over-expression based on either:
- •Immunohistochemistry (IHC) at the 3+ level, or
- •IHC 2+ confirmed by fluorescence in-situ hybridization (FISH). Tumors tested by FISH must be positive by the specific FISH assay for the amplification of HER2.
- •b. Female patients with ER positive inoperable locally advanced or metastatic breast cancer whose disease has progressed on at least one and up to 3 lines of std sequence endocrine therapy and who have received up to 2 lines of cytotoxic therapy for advanced disease.
- •2. All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression.
- •3. All patientsmust have progressive disease before entering the study.
- •4. Patients who fulfill the following criteria will be eligible for PET assessments:
- •Indications: tumor types expected to have a high FDG uptake, such as breast, lung, GIST, melanoma & colorectal cancer.
- •At least one lesion must be measurable (>2cm).
- •To be eligible for follow-up scans, patients should have uptake of the tracer in at least one lesion with a tumor-muscle ratio =2.
- •Able to lie still and flat on the PET table.
- •5. Age = 18 years.
- •6. World Health Organization (WHO) Performance Status of = 2.
- •7. Life expectancy of = 12 weeks.
- •8. 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 within normal limits or correctable with supplements
- •Total calcium (corrected for serum albumin) within normal limits or correctable with
- •supplements
- •Magnesium within normal limits or correctable with supplements
- •Phosphorus within normal limits or correctable with supplements
- •AST/SGOT and ALT/SGPT = 2.5 x Upper Limit of Normal (ULN) or = 5.0 x ULN if
- •liver metastases are present
- •Serum bilirubin = 1.5 x ULN
- •Serum albumin = 2.5g/dl
- •Serum creatinine = 1.5 x ULN or 24-hour clearance = 50 ml/min
- •Negative serum pregnancy test. The serum pregnanc
排除标准
- •1. Patients with CNS metastasis. which are symptomatic or require ttt for symptom control and/or growing. Note: patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain.
- •2. Prior treatment with any HSP90 or HDAC inhibitor compound.
- •3. Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
- •Chemotherapy within 4 weeks
- •Wide-field radiotherapy within 4 weeks
- •Localized palliative radiotherapy: within 2 weeks
- •Trastuzumab ttt within 4 weeks
- •Nitrosoureas, mitomycin and monoclonal antibodies( except trastuzumab): within 6 weeks
- •Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-
- •Wednesday-Friday dosing, weekly etc) of systemic anticancer treatment for which the recovery period is not known, or investigational drugs (i.e. targeted agents)
- •within a duration of = 5 half lives of the agent and their active metabolites (if any)
- •4. Patients who have not recovered frfom side effects of previous systemic anticancer therapy to less than grade 2 CTCAE 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 need special consideration (please refer to Post-text supplement 2 and see Section 6.6.7 for further details).
- •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. Pregnant or lactating women.
- •10. Fertile women of childbearing potential (WCBP) not using adequate contraception
- •(abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Male patients whose partners are WCBP, not using adequate contraception.
- •11. Acute or chronic liver disease.
- •12. Acute or chronic renal disease.
- •13. Other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled
- •diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
- •14. Cardiac exclusion criteria:
- •History (or family history) of long QT syndrome.
- •Mean QTc = 450 msec on screening ECG.
- •History of clinically manifest ischemic heart disease including myocardial infarction,
- •stable or unstable angina, coronary arteriography or cardiac stress testing/imaging
- •with findings consistent with coronary occlusion or infarction, = 6 months prior to
- •study start.
- •History of heart failure or left ventricular (LV) dysfunction (LVEF = 45%) by MUGA
- •Clinically significant EC
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