EUCTR2021-002672-40-PL进行中（未招募）1 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 Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer - Tucatinib + trastuzumab + mFOLFOX6 vs standard of care in 1L HER2+ metastatic colorectal cancer
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
- Seagen Inc.
- 入组人数
- 400
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
- 性别
- All
入选标准
- •1. Have histologically and/or cytologically documented adenocarcinoma of the colon or rectum, which is locally advanced unresectable or metastatic
- •2. Subjects must be willing and able to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks 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 analyzed within 1 year of biopsy date.
- •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 ECOG Performance Status (PS) of 0 or 1
- •15. CNS Inclusion:
- •a.No evidence of brain metastases; b.Previously treated brain metastases which are asymptomatic.
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •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. 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
- •8. Have ongoing = Grade 2 diarrhea of any etiology at screening
- •15. Inability to swallow pills or any significant GI disease which would preclude the adequate oral absorption of medications
- •19. Subjects with active CNS metastases (irradiated or resected lesions are permitted). See Inclusion Criteria for details. Subjects with carcinomatous meningitis are excluded without exception.
研究者
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