進行中(不再收案) NCT02584933

滾動研究:允許正於Novartis贊助研究中接受Ceritinib(LDK378)治療的患者繼續獲得Ceritinib

未指定Phase IVALK

本滾動研究將為目前正於Novartis贊助研究中接受ceritinib治療,且研究者認為可從繼續ceritinib治療中獲益的患者提供ceritinib。

適應症:ALK Positive Malignancies

收案條件

納入條件

  • Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
  • Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
  • Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
  • Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.

排除條件

  • Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason.
  • Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment.
  • Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.

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。