EUCTR2007-007885-39-GB进行中（未招募）1 期
A Phase I/II Study of HKI-272 in Combination With Vinorelbine in Subjects With Solid Tumors and Metastatic Breast Cancer.
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
- 95
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. Aged =18 years.
- •2. Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only).
- •3. Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).
- •4. At least 1 prior antineoplasic chemotherapy treatment regimen for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).
- •5. At least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks [receiving no more than 6 weeks (weekly or tri weekly schedule equivalents) for economical reason is acceptable] , for metastatic disease or subject relapsing under adjuvant treatment (part 2 only) [relapsing under adjuvant treatment” should be understood as patients still taking trastuzumab treatment or being off trastruzumab treatment for a maximal period of 6 months after the last dose of trastuzumab at the time of disease recurrence].
- •6. erbB-2 gene amplified tumor detected by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) (part 2 only). Documentation of erbB-2 status by FISH or CISH performed by a local laboratory is accepted. Otherwise, tumor tissue must be available and adequate for centralised FISH testing prior to study day 1. In case of more than 1 result, the status retrieved on the most recent biopsy should be used.
- •7. At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
- •8. Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 (not declining within 2 weeks before signing the informed consent form (ICF)).
- •9. Recovery from all clinically significant AEs related to prior therapies (excluding alopecia).
- •10. Left ventricular ejection fraction (LVEF) within the study site’s limits of normal.
- •11. Screening laboratory values within the following parameters:
- •Absolute neutrophil count (ANC): >=1.5×109/L (1500/mm3)
- •Platelet count: >=100×109/L (100,000/mm3)
- •Hemoglobin: >=9.0 g/dL (90 g/L)
- •Serum creatinine: =1.5×upper limit of normal (ULN)
- •Total bilirubin: =1.5×ULN
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): =2.5 ×
- •ULN (=5×ULN if liver metastases are present)
- •12. For women of childbearing potential, a negative urine or serum pregnancy test result before study entry.
- •13. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 28 days after the last dose of test article.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
排除标准
- •1. More than 2 prior antineoplasic treatment regimens ( excluding hormonotherapy) for metastatic disease. Subjects who relapsed under adjuvant therapy should not have received more than one line of antineoplasic treatment for metastatic disease (part 2 only).
- •2. Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.
- •3. Prior treatment with anthracyclines with a cumulative dose of doxorubicin of >400 mg/m2, or of epirubicin dose of >800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).
- •4. Major surgery, chemotherapy, radical (curative intent) radiotherapy, investigational agents, or other cancer therapy within at least 2 weeks before treatment day 1.
- •5. Subjects with bone only disease or skin lesions that are not measurable by CT or MRI as the only site of disease.
- •6. Subject with history of inflammatory breast cancer
- •7. Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- •8. QT (QTc) interval >0.47 second or known history of QTc prolongation or torsades de pointes (TdP).
- •9. 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.
- •10. Pregnant or breastfeeding women.
- •11. Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn disease, malabsorption, or grade >=2 diarrhea of any etiology at baseline).
- •12. Inability or unwillingness to swallow tablets (HKI-272).
- •13. Preexisting grade 2 or greater motor or sensory neuropathy.
- •14. Subject known to be human immunodeficiency virus (HIV) seropositive and/or acute chronic hepatitis B (HBsAg positive) or hepatitis C (anti-HCV positive).
- •15. History of known hypersensitivity to vinorelbine and any of its components.
- •16. Any other cancer within 5 years prior to screening with the exception of contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
- •17. Clinically significant ongoing or recent infection within 2 weeks before treatment day 1.
- •18. Evidence of significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, make the subject inappropriate for this study.
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