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Trial record 14 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02751385
First received: April 22, 2016
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
Investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a combination of ethinylestradiol and levonorgestrel (Microgynon®)

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Microgynon
Drug: Nintedanib
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC 0-tz (area under the concentration-time curve of ethinylestradiol before nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]
  • AUC 0-tz (area under the concentration-time curve of levonorgestrel before nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]
  • AUC 0-tz (area under the concentration-time curve of ethinylestradiol after continuous nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]
  • AUC 0-tz (area under the concentration-time curve of levonorgestrel after continuous nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]
  • Cmax (maximum measured concentration) of ethinylestradiol before nintedanib administration in plasma [ Time Frame: at week 3 ]
  • Cmax (maximum measured concentration) of levonorgestrel before nintedanib administration in plasma [ Time Frame: at week 3 ]
  • Cmax (maximum measured concentration) of ethinylestradiol after continuous nintedanib administration in plasma [ Time Frame: at week 3 ]
  • Cmax (maximum measured concentration) of levonorgestrel after continuous nintedanib administration in plasma [ Time Frame: at week 3 ]

Secondary Outcome Measures:
  • AUC0-infinity (area under the concentration-time curve of ethinylestradiol before nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]
  • AUC0-infinity (area under the concentration-time curve of levonorgestrel before nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]
  • AUC0-infinity (area under the concentration-time curve of ethinylestradiol after continuous nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]
  • AUC0-infinity (area under the concentration-time curve of levonorgestrel after continuous nintedanib administration in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: at week 3 ]

Estimated Enrollment: 14
Actual Study Start Date: May 20, 2016
Estimated Study Completion Date: December 29, 2017
Estimated Primary Completion Date: December 29, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Patients
Microgynon alone in Period 1 then with Nintedanib in Period 2
Drug: Microgynon Drug: Nintedanib

Detailed Description:
Purpose:
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02751385

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Germany
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09116
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany, 30625
Universitätsklinikum des Saarlandes Not yet recruiting
Homburg/Saar, Germany, 66421
Praxis Dr. Gessner, Leipzig Recruiting
Leipzig, Germany, 04357
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02751385     History of Changes
Other Study ID Numbers: 1199.238
2015-005664-41 ( EudraCT Number )
Study First Received: April 22, 2016
Last Updated: April 19, 2017

Additional relevant MeSH terms:
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Nintedanib
Ethinyl Estradiol
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Levonorgestrel
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on April 27, 2017