Clinical trial NCT02751385: Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer
Official title: A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed description: Purpose:

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

Primary outcomes:
measure: Area Under the Concentration-time Curve of the the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: Please refer to description section for the details about the actual sampling time points
measure: Maximum Measured Concentration (Cmax) of Ethinylestradiol and Levonorgestrel
timeFrame: Please refer to description section for the details about the actual sampling time points
Secondary outcomes:
measure: Area Under the Concentration-time Curve of the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity).
timeFrame: Please refer to description section for the details about the actual sampling time points
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: