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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 logo

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

All Patients
Experimental group
Description:
Microgynon alone in Period 1 then with Nintedanib in Period 2
Treatment:
Drug: Microgynon
Drug: Nintedanib

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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