NL-OMON56153招募中3 期
An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumabas First-line Treatment for Subjects with HER2+Metastatic Colorectal Cancer - MOUNTAINEER-03
Seagen, Inc0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must meet the following criteria to be eligible for the study:
- •1. Have histologically and/or cytologically documented adenocarcinoma of the
- •colon or rectum, which locally advanced or metastatic
- •2. Subjects must be willing and able to provide the most recently available
- •formalin-fixed paraffin-embedded tumor tissue blocks (or freshly sectioned
- •slides, see laboratory manual for details), obtained prior to treatment
- •initiation, to a sponsor-designated central laboratory for biomarker analysis.
- •If archival tissue is not available, then a newly- obtained baseline biopsy of
- •an accessible tumor lesion is required within 35 days prior to the Cycle 1 Day
- •1 timeframe. Biopsy must provide adequate tissue for analysis; the following
- •biopsy types are acceptable: resection, excision, punch (skin lesions only) and
- •core needle biopsies.
- •3. Have HER2+ disease as determined by tissue-based investigational HER2 IHC
- •and ISH assays performed at a sponsor-defined central laboratory. HER2
- •amplification will be determined using ASCO/CAP guidelines for gastric and
- •gastroesophageal cancer with IHC 3+ or IHC 2+/ISH+ result.
- •4. Have RAS WT disease as determined by local or central testing (if local
- •testing is unavailable or is not preferred). For central RAS analysis, tissue
- •sample must be analysed within 1 year of biopsy.
- •5. Age >=18 years at time of consent and >= the age of majority per regional
- •requirements
- •6. Have radiographically measurable disease per RECIST v1.1 according to INV
- •assessment, with at least one
- •site of disease that is measurable and that has not been previously irradiated;
- •or, if the subject has had previous radiation to the target lesion(s), there
- •must be evidence of progression since the radiation
- •7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of
- •8. Life expectancy of >=3 months, in the opinion of the investigator
- •9. Have adequate hematological, hepatic, renal, coagulation, and cardiac
- •function, as defined below, obtained <=7 days prior to enrollment (Cycle 1 Day
- •a. Absolute neutrophil count (ANC) >=1.5 × 103/µL
- •b. Platelet count >=100 × 103/µL
- •c. Hemoglobin >=9.0 g/dL
- •d. Total bilirubin <=1.5 × upper limit of normal (ULN). Subjects with known
- •history of Gilbert*s Syndrome may enroll if direct bilirubin is <=1.5 × ULN
- •e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 × ULN
- •(<=5 × ULN if liver
- •metastases are present)
- •f. Creatinine level <=1.5 × institutional ULN or estimated creatinine clearance
- •>=60 mL/min for subjects with
- •creatinine levels >1.5 × institutional ULN
- •g. International normalized ratio (INR) and activated partial thromboplastin
- •time (aPTT) <=1.5 × ULN unless on medication known to alter INR and/or aPTT
- •h. Left ventricular ejection fraction (LVEF) >=50% as assessed by echocardiogram
- •(ECHO) or multiple-gated acquisition (MUGA) scan documented <=28 days prior to
- •study treatment
- •10. For subjects of childbearing potential, the following stipulations apply:
- •a. Must have a negative serum pregnancy test (minimum sensitivity of 25 mIU/mL
- •or equivalent units of beta human chorionic gonadotropin [β-hCG]) result within
- •7 days prior to the first dose of study treatment. A subject with a false
- 另有 1 项未显示
排除标准
- •Subjects will be excluded from the study for any of the following reasons:
- •1. Have previously received any systemic anticancer therapy for CRC in the
- •metastatic setting or have participated in any interventional clinical trial
- •for CRC in the metastatic setting.
- •Note: that subjects may have received a maximum of 2 doses of mFOLFOX6 in the
- •locally advanced/unresectable or metastatic setting prior to randomization.
- •Note: Subjects may have received prior chemotherapy for CRC in the adjuvant
- •setting provided that it was completed >6 months prior to enrollment.
- •2. Have previously received radiation therapy within 14 days prior to
- •enrollment (or within 7 days in the setting of SRS). Subjects who have received
- •prior radiation therapy must have recovered to baseline from any treatment-
- •related adverse events (AEs). Subjects who have received palliative
- •radiotherapy for symptomatic metastases
- •may enter the study without a washout period provided that the subject has
- •recovered from any treatment-related AEs.
- •3. Have previously been treated with anti-HER2 therapy
- •4. Have any toxicity related to prior cancer therapies that has not resolved to
- •<= Grade 1, with the following exceptions:
- •Neuropathy, which must have resolved to <= Grade 2
- •Congestive heart failure (CHF), which must have been <= Grade 1 in severity at
- •the time of occurrence, and must have resolved completely
- •Anemia, hemoglobin must have resolved to a level of >=9.0 g/dL
- •5. Have clinically significant cardiopulmonary disease such as:
- •Ventricular arrhythmia requiring therapy
- •Symptomatic hypertension or uncontrolled asymptomatic hypertension, as
- •determined by the investigator
- •Any history of symptomatic CHF (Grade 2 or above), symptomatic left
- •ventricular systolic dysfunction or symptomatic decrease in ejection fraction
- •Severe dyspnea at rest (Grade 3 or above) due to complications of advanced
- •malignancy or hypoxia requiring supplementary oxygen therapy
- •Presence of >= Grade 2 corrected QT interval (QTc) prolongation (>480 ms) on
- •screening electrocardiogram
- •Interstitial lung disease or pneumonitis
- •Have a history of transient ischemic attack, cerebrovascular accident,
- •myocardial infarction, unstable angina, cardiac or other vascular stenting,
- •angioplasty, or cardiac surgery within 6 months prior to enrollment (Cycle 1
- •6. Have a history of a significant bleeding events within 6 months of
- •enrollment, unless the source of bleeding has been definitively treated
- •7. Have a history of gastrointestinal (GI) perforation within 12 months of
- •8. Have ongoing >= Grade 2 diarrhea of any etiology
- •9. Major surgical procedure or significant traumatic injury <=28 days prior to
- •enrollment (<=56 days for hepatectomy, open thoracotomy, or major neurosurgery)
- •or anticipation of need for major surgical procedure during the course
- •of the study
- •10. Serious, non-healing wound, ulcer, or bone fracture
- •11. Positive for hepatitis B by surface antigen expression or presence of known
- •chronic liver disease
- •12. Have active hepatitis C infection (positive by PCR or on antiviral therapy
- •for hepatitis C within the last 6 months). Subjects who have been treated for
- •hepatitis C infection are permitted if they have documented
- 另有 1 项未显示
研究者
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