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

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Microgynon

Drug: Nintedanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02751385

1199.238

2015-005664-41 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Purpose:

Enrollment

2 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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