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進行中（不再收案） NCT02568267

Entrectinib（RXDX-101）用於治療帶有 NTRK 1/2/3（Trk A/B/C）、ROS1 或 ALK 基因重排（融合）的實體瘤患者的籃式研究

非小細胞肺癌乳癌大腸直腸癌卵巢癌胰臟癌淋巴瘤黑色素瘤頭頸癌腎癌膽道癌甲狀腺癌腦瘤肉瘤神經內分泌腫瘤Phase IIIII 期IV 期ALKROS1NTRK

這是一項開放標籤、多中心、全球性的第二期籃式研究，評估 entrectinib（RXDX-101）用於治療帶有 NTRK1/2/3、ROS1 或 ALK 基因融合的實體瘤患者。患者將根據腫瘤類型和基因融合被分配至不同的籃子。

適應症：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

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。