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

NCT ID: NCT02751385

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-20
• Study Completion Date: 2017-11-28

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:

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All Patients

Microgynon alone in Period 1 then with Nintedanib in Period 2

Group Type: EXPERIMENTAL

Microgynon

Intervention Type: DRUG

Nintedanib

Intervention Type: DRUG

Interventions

Microgynon

Intervention Type: DRUG

Nintedanib

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-005664-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.238

Identifier Type: -

Identifier Source: org_study_id