Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Microgynon; Nintedanib
Intervention MeSH terms: Nintedanib; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a
      combination of ethinylestradiol and levonorgestrel (Microgynon®)
    

Eligibility criteria:

        Inclusion criteria:

          -  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

        Exclusion criteria:

          -  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 pharmacokinetic(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
             months

          -  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