EUCTR2012-001547-46-ES进行中（未招募）1 期
Phase I followed by phase II study of the combination of trastuzumab emtansine (T-DM1) and capecitabine in HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
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
- All
入选标准
- •For mBC Patients:
- •1.Age ? 18 years old
- •2.Signed informed consent prior to any study specific procedure
- •3.Able and willing to comply with protocol
- •4.Negative serum pregnancy test for women of childbearing potential (including pre menopausal women who have had a tubal ligation) and for all women not meeting the definition of postmenopausal ( ? 12 months of amenorrhea), and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential
- •5.For women of childbearing potential and men with partners of childbearing potential, agreement by the patient and/or partner to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception and to continue its use for the duration of study treatment and for 6 months after the last dose of study treatment (see Section 5.2.4)
- •6.ECOG performance status of 0, 1, or 2
- •7.Blood: a)Platelet count > 100,000 cells/mm3
- •b)International normalized ratio (INR) < 1.5 × the upper limit of normal (ULN)
- •c)Absolute neutrophil count (ANC) > 1500 cells/mm3
- •d)Hemoglobin > 9.0 g/dL. Patients are allowed to have received transfusion to achieve this level.
- •8.Liver function:
- •a)Total bilirubin ? 1.5 × ULN except in patients with previously documented Gilbert?s syndrome in which case total bilirubin ? 3 mg/dL is acceptable
- •b)Serum glutamic oxaloacetic transaminase (SGOT)/AST and serum glutamic pyruvic transaminase (SGPT)/alanine transaminase (ALT) ? 2.5 × the ULN
- •c)Alkaline phosphatase ? 2.5 × the ULN. Patients with hepatic and/or bone metastases: alkaline phosphatase ? 5 × the ULN
- •9.Renal function:
- •a)Serum creatinine of < 177 µmol/L or calculated creatinine CL > 50 mL/min. I urine dipstick for proteinuria is ? 2+ at baseline, the patient must undergo 24 hour urine collection and demonstrate ? 1 g of protein/24 hours
- •10.Cardiac function:
- •a)LVEF ? 50% by echocardiogram (ECHO) or multiple gated acquisition (scan) (MUGA)
- •11.Histologically or cytologically confirmed breast cancer
- •12.HER2-positive disease IHC 3+ or ISH positive
- •13.Tumor block available or 15 slides for retrospective central confirmation of HER2-positivity (central confirmation not necessary for enrolment)
- •14.Metastatic breast cancer (mBC) with at least one measurable lesion according to RECIST
- •15.Disease progression on at least one regimen containing trastuzumab and chemotherapy
- •16.Patients must have recovered from previous treatments
- •For mGC Patients: Inclusion criterias 1-10 same as mBC.
- •11.Histologically or cytologically confirmed GC
- •12.HER2 positive tumor (primary tumor or metastatic lesion), defined as either IHC 3+ alone or IHC 2+ in combination with ISH+, prospectively confirmed by a Sponsor-designated central laboratory prior to enrollment. ISH positivity is defined as a ratio of ? 2.0 for the number of HER2 gene copies to the number of signals for CEP17.
- •a)Archival tumor samples obtained from primary or metastatic sites are acceptable.
- •b)Invasive tumor for central confirmation of HER2 status is required.
- •c)A formalin-fixed paraffin-embedded (FFPE) tissue block with at least 5 mm of invasive tumor for central confirmation is preferred.
- •If FFPE tissue blocks (or partial block) are unavailable due to country or site regulations, a minimum of 8 freshly cut unstained slides MUST be available for central review of HER2 status.
- •13. Inoperable locally advan
排除标准
- •For mBC Patients:
- •1. Prior treatments before first study treatment
- •a)Investigational therapy within ? 28 days or 5 half lives, whatever is longest
- •b)Hormonal therapy within 14 days
- •c)Trastuzumab within 21 days
- •2.Prior enrollment in a trastuzumab emtansine?containing study, regardless of whether the patient received prior trastuzumab emtansine
- •3.Prior treatment with capecitabine
- •4.History of severe and unexpected reactions to fluoropyrimidine or with known hypersensitivity to fluorouracil
- •5.Related capecitabine contraindications:
- •a)Treatment with sorivudine or its chemically related analogues, such as brivudine
- •b)Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •6.History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins
- •7.History of exposure to the following cumulative doses of anthracyclines:
- •a)Doxorubicin or liposomal doxorubicin > 360 mg/m2
- •b)Epirubicin > 900 mg/m2
- •c)Mitoxantrone > 120 mg/m2
- •d)If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 360 mg/m2 doxorubicin.
- •8.Brain metastases that are symptomatic, or require any radiation, surgery, or steroid therapy to control their symptoms within 28 days of first study drug administration
- •9.Current peripheral neuropathy of Grade ? 3 per the NCI CTCAE, v4.0
- •10.History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
- •11.Current unstable ventricular arrhythmia requiring treatment
- •12.History of symptomatic CHF (New York Heart Association [NYHA] Classes II?IV)
- •13.History of myocardial infarction or unstable angina within 6 months prior to first study drug administration
- •14.History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment
- •15.Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
- •16.Clinically significant malabsorption syndrome or inability to take oral medication
- •17.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- •18.Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
- •19.Current pregnancy or lactation
- •20.Current known active infection with human influenca virus (HIV), hepatitis B, and/or hepatitis C virus
- •a)For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines
- •21.Lapatinib ? 14 days before first study drug administration
- •22.Previous radiotherapy for the treatment of unresectable, locally advanced/recurrent or mBC is not allowed if:
- •a)The last fraction of radiotherapy has been administered within 14 days prior to first study drug administration.
- •b)More than 25% of marrow-bearing bone has been irradiated.
- •c)The patient has not recovered from any resulting acute toxicity to Grade ? 1 prior to first study drug administration.
- •For mGC Patients: Exclusion criterias 1- 20 same as mBC.
- •21.Previous chemotherapy for advanced/metastatic disease
- •a)Prior adjuvant/neoadjuvant ther
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