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进行中（不再招募） NCT02568267

Entrectinib（RXDX-101）用于治疗带有 NTRK 1/2/3（Trk A/B/C）、ROS1 或 ALK 基因重排（融合）的实体瘤患者的篮式研究

非小细胞肺癌乳腺癌结直肠癌卵巢癌胰腺癌淋巴瘤黑色素瘤头颈癌肾癌胆道癌甲状腺癌脑瘤肉瘤神经内分泌肿瘤Phase IIIII 期IV 期ALKROS1NTRK

这是一项开放标签、多中心、全球性的第二期篮式研究，评估 entrectinib（RXDX-101）用于治疗带有 NTRK1/2/3、ROS1 或 ALK 基因融合的实体瘤患者。患者将根据肿瘤类型和基因融合被分配至不同的篮子。

适应症：Breast Cancer、Cholangiocarcinoma、Colorectal Cancer、Head and Neck Neoplasms、Lymphoma, Large-Cell, Anaplastic、Melanoma、Neuroendocrine Tumors、Non-Small Cell Lung Cancer、Ovarian Cancer、Pancreatic Cancer、Papillary Thyroid Cancer、Primary Brain Tumors、Renal Cell Carcinoma、Sarcomas、Salivary Gland Cancers、Adult Solid Tumor

入组条件

纳入标准

  • Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
  • For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
  • Measurable or evaluable disease
  • Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
  • Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)
  • \- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
  • At least 4 weeks must have elapsed since completion of antibody-directed therapy
  • Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
  • Adequate organ function as defined per protocol
  • Ability to swallow entrectinib intact
  • Other protocol specified criteria

排除标准

  • Current participation in another therapeutic clinical trial
  • Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
  • \- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
  • History of other previous cancer that would interfere with the determination of safety or efficacy
  • Familial or personal history of congenital bone disorders, or bone metabolism alterations
  • Incomplete recovery from any surgery
  • History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study
  • History of non-pharmacologically induced prolonged QTc interval
  • History of additional risk factors for torsades de pointes
  • Peripheral neuropathy Grade ≥ 2
  • Known active infections
  • Active gastrointestinal disease or other malabsorption syndromes
  • Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
  • Other protocol specified criteria

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。