A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) - A pilot study of nintedanib for lymphangioleiomyomatosis (LAM)

MULTIMEDICA S.P.A.0 个研究点目标入组 30 人开始时间: 2016年8月11日最近更新: 2016年8月16日

试验速览

暂无简介。

•1. Written Informed Consent for participating to trial e to genetic tests,
•2. Patient aged = 18 years at visit 1,
•3. sporadic or TSC associated LAM, classified as ‘‘definite’’ by the European Respiratory Society
•criteria and /or serum VEGFD level >/= 800 mg/ml, and evidence of a 10% deterioration in FEV1
•and /or loss of 80 ml of FEV1 or more in the last year (post bronchodilator). Also LAM patients
•with proven side effects and/or toxicities/ contraindications to sirolimus therapy will be eligible for this study.
•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 28
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Previous treatment with nintedanib
•Other investigational therapy (participation in research trial) received within 8 weeks of visit
•Thoracic, abdominal, gynecological, neurologic surgical procedures planned to occur during
•trial period.
•Pregnant women or women who are breast feeding or of child bearing potential not using
•two effective methods of birth control (one barrier and one highly effective non-barrier) for
•at least 1 month prior to enrolment (and until 3 months after treatment end).
•Female patients will be considered to be of childbearing potential unless surgically sterilised
•by hysterectomy or bilateral tubal ligation, or postmenopausal for at least two years or if
•women use a barrier method of contraception includes condom or occlusive cap with
•spermicidal (foam, gel, film, cream, suppository) or male sterilization (with appropriate
•post-vasectomy documentation of the absence of sperm in the ejaculate), or if they use an
•intrauterine device
•· International normalized ratio (INR) > 2 at visit 1

发起方

MULTIMEDICA S.P.A.