EUCTR2008-001662-85-HU进行中（未招募）1 期
A Phase 1/2 Open-label Study of Neratinib (HKI-272) in combination with Capecitabine in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or Locally advanced Breast Cancer
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 110 人开始时间: 2008年10月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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
- •1. Male (part 1 only) and female subjects aged 18 years or older.
- •2. Subjects enrolled in Part 1 must have confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
- •3. Subjects enrolled in Part 2 must have a histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
- •4. Subjects enrolled in Part 2 must have erbB-2 gene amplified tumor. Documentation of erbB-2 status by FISH or CISH, or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation) based on local testing is accepted. Otherwise, tumor tissue must be available and adequate for centralized FISH testing prior to study day 1. In case of more than one result, the status retrieved on the most recent biopsy should be used.
- •5. Subjects enrolled in Part 2 must have disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
- •6. Subjects enrolled in Part 2 must have received prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
- •7. At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. (please note: ascites, pleural or pericardal effusion, osteoblastic bone metastases, and carcinomatous lymphangitis of the lung will not be considered measurable lesions). Subjects with skin lesions that are measurable by CT scans or MRI as the only site of measurable disease are allowed.
- •8. Eastern Cooperative Oncology Group (ECOG) status of 0 to 2, not declining within two weeks before informed consent signing.
- •9. Recovery from all clinically significant adverse effects related to prior therapies (excluding alopecia).
- •10. Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).
- •11. Screening laboratory values within the following parameters:
- •- ANC: = 1.5 × 109/L (1,500/mm3)
- •- Platelet count: = 75 × 109/L (75,000/mm3)
- •- Hemoglobin: = 9.0 g/dL (90g/L)
- •- Serum creatinine: = 1.5 x upper limit of normal (ULN)
- •- Total bilirubin: =1.5 × ULN (< 3 ULN if Gilbert's disease)
- •- AST and ALT: = 2.5 × ULN = 5 x ULN if liver metastases are present)
- •12. For women of child bearing potential, a negative urine or serum pregnancy test result before study entry. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
- •13. All subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control starting 2 weeks prior to administration of the first dose of test article, until 28 days after the last dose of test article. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives. Oral contraceptives may not be used as the sole form of birth control for this study; oral contraceptives m
排除标准
- •1. Subjects enrolled in Part 2 must have received no prior treatment with capecitabine, lapatibine ( excluding 20 subjects enrolled with prior treatment lapatinib) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
- •2. Subjects enrolled in Part 2 must not have received prior treatment with anthracyclines with a cumulative dose of doxorubicin of > 400 mg/m2, epirubicin dose of >800 mg/m2, or the equivalent dose for other anthracyclines.
- •3. Major surgery, chemotherapy, radiotherapy, any investigational agents, or other cancer therapy within 2 weeks of treatment day 1.
- •4. Subjects with bone as the only site of disease.
- •5. Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated, and are off convulsivants and steroids for at least 4 weeks before the first dose of test article.
- •6. Family history of congenital long or short QT syndrome, Bruganda syndrome or subjects with a QT/QTc interval >0.45 second or known history of QTc prolongation, or Torsade de Pointes (TdP).
- •7. Presence of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association [NYHA] functional classification of = 2), angina requiring treatment, myocardial infarction within the past 12 months, or any clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
- •8. Pregnant, or breast-feeding, or women of child bearing potential who are not using effective contraception during participation in the study and do not agree to do so for at least 28 days after the final dose of test article.
- •9. Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or Grade
- •10. Inability or unwillingness to swallow tablets or capsules.
- •11. Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
- •12. Any major medical illness or abnormal laboratory finding that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of the study. Examples include, but are not limited to, serious active infection (i.e. requiring intravenous antibiotic or antiviral agent), uncontrolled major seizure disorder, significant pulmonary disorder (e.g. interstitial pneumonitis, pulmonary hypertension), or psychiatric disorder that would interfere with subject safety or informed consent.
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