Last updated on March 2019

Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Small-Cell Lung | Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other:
    Female patients 18 years or older at screening
    Female patient is postmenopausal or surgically sterilised
    Patient with locally advanced, metastatic or locally recurrent non-small cell lung
    cancer with histology of adenocarcinoma
    Nintedanib (Vargatef®) is planned to be prescribed in accordance with the marketing
    authorisation (SmPC)
    Signed and dated written informed consent in accordance with Good Clinical Practice
    (GCP) and local legislation prior to admission to the trial

You may not be eligible for this study if the following are true:

  • Any contraindication to nintedanib (Vargatef®), ethinylestradiol or levonorgestrel
    (Microgynon®), as specified in the respective labels
    Use of hormone containing contraceptives (including vaginal and intrauterine devices
    and including hormone replacement therapy) within 30 days prior to first
    administration of Microgynon®
    Systemic use of drugs known to induce (e.g. rifampicin, St. John's Wort,
    carbamazepine) or to inhibit (e.g. azole antimycotics, macrolides) CYP3A4 within 7
    days prior to first trial drug administration until last PK-sampling in the trial.
    Exception: allowed is the intake of corticosteroids as docetaxel (pre)medication
    History of major thrombotic or clinically relevant major bleeding event in the past 6
    Persistence of clinically relevant therapy related toxicities (i.e. > Common
    Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous chemotherapy
    and/or radiotherapy
    Treatment with other investigational drugs or treatment in another clinical trial
    within the past four weeks before start of therapy or concomitantly with this trial
    Gastrointestinal disorders or abnormalities that would interfere with absorption of
    the trial drugs
    Major surgery (major according to the investigator's assessment) performed within 4
    weeks prior to first treatment within the trial and without complete wound healing
    Patients who must or wish to continue the intake of restricted medications or any drug
    considered likely to interfere with the safe conduct of the trial
    Patients unable to comply with the protocol
    Previous enrolment in this trial

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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