EUCTR2014-002286-30-GB进行中（未招募）不适用
PHASE 2 STUDY OF SINGLE-AGENT PF 03084014 IN PATIENTS WITH ADVANCED TRIPLE-NEGATIVE BREAST CANCER WITH OR WITHOUT GENOMIC ALTERATIONS IN NOTCH RECEPTORS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- Female
入选标准
- •1.Histological or cytological diagnosis of triple negative breast cancer (TNBC) with evidence of a) metastatic or b) locally recurrent advanced disease that is not amenable to resection or radiotherapy with curative intent.
- •For France: Histological diagnosis of triple negative breast cancer (TNBC) with evidence of a) metastatic or b) locally recurrent advanced disease that is
- •not amenable to resection or radiotherapy with curative intent.
- •In all patients, documentation of ER/PR-negative status and HER2/neu receptor- negative status (ie, by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) [where approved] negative or immunohistochemistry (IHC) 0 or +1) on archival biopsy.
- •2.De novo or previously treated advanced disease in patients whose tumors are NA + provided they have no impending vital organ compromise (visceral).
- •For France and Germany: previously treated with 1 or more prior therapies for advanced disease in patients whose tumors are NA +.
- •3.Previously treated with 1 or more prior therapies for advanced disease in patients whose tumors are NA-.
- •For France and Germany: Patients whose tumors are NA- are excluded from enrollment.
- •4.At least one measurable tumor lesion as defined by RECIST version 1.1.
- •5.Availability of an original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) a peripheral blood sample for Notch receptors genomic profiling:
- •In at least 28 patients, detectable genomic alteration in Notch 1, 2, 3, or 4 receptor in original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) as defined by a CLIA-certified NGS assay; presence of Notch 1, 2, 3, or 4 receptor activating alterations must be confirmed by comparison to the germline status, as detected in the peripheral blood sample;
- •In at least 20 patients, no detectable genomic alteration in Notch 1, 2, 3, or 4 receptor in original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) as defined by a CLIA-certified NGS assay.
- •6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
- •7.Female, age = 18 years.
- •8.Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1 except for those AEs not constituting a safety risk by Investigator judgment.
- •9.Adequate Bone Marrow Function, including:
- •Absolute Neutrophil Count (ANC) =1,500/µL or =1.5 x 1 000 000 000/L;
- •Platelets =100,000/µL or =100 x 1 000 000 000/L;
- •Hemoglobin =9 g/dL.
- •10.Adequate Renal Function, including:
- •Serum creatinine =1.5 x upper limit of normal (ULN) or estimated creatinine clearance =60 mL/min as calculated using the method standard for the institution.
- •11.Adequate Liver Function, including:
- •Total serum bilirubin =1.5 x ULN unless the patient has documented Gilbert syndrome;
- •Aspartate and Alanine Aminotransferase (AST and ALT) =2.5 x ULN; =5.0 x ULN if there is metastatic liver disease;
- •Alkaline phosphatase =2.5 x ULN; (=5 x ULN in case of bone metastasis).
- •12.Serum/urine pregnancy test (for patients of childbearing potential) negative at screening.
- •13.Patients of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
- •Patients who are not of childbearing potential (ie, meet at least 1 of
排除标准
- •1.Known brain metastases.
- •2.Major surgery within 4 weeks of study entry.
- •3.Radiation therapy within 4 weeks of study entry; a previously irradiated lesion is non-measurable unless it has progressed since completion of radiation treatment.
- •4.Systemic anti cancer therapies within 2 weeks of study entry.
- •5.Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor.
- •6.Participation in other studies involving investigational drug(s) (Phases 1-4) within 2 weeks before the current study begins and/or during study participation.
- •7.Current use or anticipated need for treatment with other anti-cancer drugs.
- •8.Known malabsorption syndrome or other condition that may impair absorption of PF 03084014 (eg, gastric bypass or lap band).
- •9.Active and clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •10.Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
- •11.QTc interval >470 msec (mean of triplicate electrocardiogram (ECG) readings).
- •12.Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or adequately treated carcinoma in situ of the cervix.
- •13.Pregnant or breastfeeding patients.
- •14.Current use or anticipated need for food or drugs that are strong/moderate CYP3A4/5 inhibitors, including their administration within 7 days prior to study entry. Refer to Appendix 3 and Appendix 4 for a list of strong and moderate inhibitors.
- •15.Current use or anticipated need for food or drugs that are strong CYP3A4/5 inducers, including their administration within 7 days prior to study entry. Refer to Appendix 5 for a list of strong inducers.
- •16.Current use or anticipated need for treatment with oral anti vitamin K agents or other oral anti coagulants. Treatment with therapeutic doses of low-molecular weight heparin is allowed.
- •17.Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.
- •18.Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
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