EUCTR2021-002672-40-IT招募中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
- 招募中
- 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 metastatic and/or unresectable
- •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)
- •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 brainmetastases 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. 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 >or= 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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