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Trial record 32 of 403 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT02751385
Recruitment Status : Terminated (Terminated- Study halted due to low recruitment.)
First Posted : April 26, 2016
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 22, 2016
First Posted Date  ICMJE April 26, 2016
Results First Submitted Date  ICMJE November 22, 2018
Results First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE May 20, 2016
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2018)
  • 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) [ Time Frame: Please refer to description section for the details about the actual sampling time points ]
    Area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC 0-tz) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration. In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®.
  • Maximum Measured Concentration (Cmax) of Ethinylestradiol and Levonorgestrel [ Time Frame: Please refer to description section for the details about the actual sampling time points ]
    Maximum blood concentrations (Cmax) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration. In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
  • 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 ]
Change History Complete list of historical versions of study NCT02751385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2018)
Area Under the Concentration-time Curve of the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity). [ Time Frame: Please refer to description section for the details about the actual sampling time points ]
Area under curve from zero to infinity (AUC0-∞) for ethinylestradiol and for levonorgestrel after intake of a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration. In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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:
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Microgynon
  • Drug: Nintedanib
Study Arms  ICMJE Experimental: All Patients
Microgynon alone in Period 1 then with Nintedanib in Period 2
Interventions:
  • Drug: Microgynon
  • Drug: Nintedanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 19, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2016)
14
Actual Study Completion Date  ICMJE November 28, 2017
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02751385
Other Study ID Numbers  ICMJE 1199.238
2015-005664-41 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP