Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Reproductive Control Agents

All Drugs and Chemicals

Antineoplastic Agents

Ethinyl Estradiol

Levonorgestrel

Nintedanib

Ethinyl Estradiol-Norgestrel Combination

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Ethinyl estradiol, levonorgestrel drug combination

Norgestrel

Protein Kinase Inhibitors

Enzyme Inhibitors

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptives, Oral

Contraceptives, Oral, Combined

Contraceptive Agents, Female

Contraceptives, Oral, Hormonal

Contraceptives, Postcoital

Microgynon alone in Period 1 then with Nintedanib in Period 2

Microgynon

Boehringer Ingelheim

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

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

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

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 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®.

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®.

Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.

Microgynon®

Loading Nintedanib

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg if required) for at least 7 consecutive days in Period 2. Nintedanib was to be taken continuously throughout in Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they have taken nintedanib for at least 7 consecutive days before intake of Microgynon®.

Nintedanib+Microgynon®

Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.

Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®. Same subjects were continued to Period 2, hence baseline characteristics are presented by Period 1.

All Patients

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Treated set (TS)- This patient set includes all patients in the Entered Set (ES) who were documented to have received one dose of study drug.

Boehringer Ingelheim, Call Center

Ethinylestradiol

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.

Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®.

Microgynon® With Nintedanib

Pharmacokinetic Set (PKS): This analysis set includes all patients in the Treated Set (TS) who contributes only one PK parameter value for one period to the statistical assessment.

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)

Pharmacokinetic Set (PKS): This analysis set includes all patients in the TS who contributes only one PK parameter value for one period to the statistical assessment.

Maximum Measured Concentration (Cmax) of Ethinylestradiol and Levonorgestrel

Area Under the Concentration-time Curve of the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity).

Period 1

Period 2

Spots Global Cancer Trial Database for 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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Conditions

Interventions

Study Description

Keywords

Eligibility

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