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The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.
Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m^2) and to determine the Recommended Dose (RD) for the phase II part.
Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m^2) as compared to pemetrexed (500 mg/m^2) + placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBF 1120 BID + Pemetrexed | Experimental | Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m^2 pemetrexed once every 3 weeks |
|
| BIBF 1120 BID (RD) + Pemetrexed | Experimental | PHase II part: Study arm |
|
| BIBF 1120 BID(Placebo) + Pemetrexed | Experimental | Phase II part: Comparator arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBF 1120 M + Pemetrexed | Drug | BIBF 1120 medium dose bid+ Pemetrexed 500 mg/m^2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course | During the first course, 21 days |
| Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses | Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE). | Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 | Every 6 weeks after start of study treatment until end of treatment, up to 992 days |
| Disease Control Rate |
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Inclusion criteria:
Male or female patients of age >=20 and <=74 years at informed consent
Histologically or cytologically confirmed, Non Small Cell Lung Cancer (NSCLC) of stage IIIB or IV or recurrent NSCLC
Relapse or failure of 1 first-line prior chemotherapy
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Patients who have sufficient baseline organ function over 4 weeks and whose laboratory data meet the following criteria at the enrolment
Patient has given written informed consent which must be consistent with ICH-GCP and local legislation.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1199.28.003 Boehringer Ingelheim Investigational Site | Chiba,Kashiwa | Japan | ||||
| 1199.28.002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26560486 | Derived | Daga H, Takeda K, Okada H, Miyazaki M, Ueda S, Kaneda H, Okamoto I, Yoh K, Goto K, Konishi K, Sarashina A, Tanaka T, Kaiser R, Nakagawa K. Phase I study of nintedanib in combination with pemetrexed as second-line treatment of Japanese patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Dec;76(6):1225-33. doi: 10.1007/s00280-015-2896-3. Epub 2015 Nov 11. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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19 patients were enrolled in the study however one patient did not meet the inclusion criteria and therefore did not participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIBF 1120 100 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Combination Treatment Phase |
|
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| BIBF 1120 H + Pemetrexed | Drug | BIBF 1120 high dose bid+ Pemetrexed 500 mg/m^2 |
|
| BIBF 1120 RD + Pemetrexed | Drug | confirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m^2 |
|
| BIBF 1120 L + Pemetrexed | Drug | BIBF 1120 low dose bid+ Pemetrexed 500 mg/m^2 |
|
| BIBF 1120 Placebo + Pemetrexed | Drug | placebo BIBF 1120 bid + Pemetrexed 500 mg/m^2 |
|
Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 |
| Every 6 weeks after start of study treatment until end of treatment, up to 992 days |
| Duration of Disease Control | Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier. | From first study drug administration until PD or death, up to 1003 days |
| Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters | Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in >= 20% of patients | Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days |
| AUC0-inf of Nintedanib | Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) | 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1 |
| Cmax of Nintedanib | Maximum measured concentration of nintedanib in plasma (Cmax) | 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1 |
| AUC0-inf of Pemetrexed | Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) | 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2 |
| Cmax of Pemetrexed | Maximum measured concentration of pemetrexed in plasma (Cmax) | 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2 |
| Miyakojima-ku, Osaka |
| Japan |
| 1199.28.001 Boehringer Ingelheim Investigational Site | Osaka-Sayama, Osaka | Japan |
| FG001 | BIBF 1120 150 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
| FG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Combination Followed by Monotherapy |
|
|
Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | BIBF 1120 100 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
| BG001 | BIBF 1120 150 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
| BG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Limiting Toxicities | Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course | Treated set | Posted | Number | Participants | During the first course, 21 days |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses | Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE). | Treated set | Posted | Number | participants | Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 | Treated set | Posted | Number | Participants | Every 6 weeks after start of study treatment until end of treatment, up to 992 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate | Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 | Treated set | Posted | Number | Participants | Every 6 weeks after start of study treatment until end of treatment, up to 992 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Disease Control | Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier. | Patients from the treated set who achieved disease control | Posted | Median | Full Range | Days | From first study drug administration until PD or death, up to 1003 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters | Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in >= 20% of patients | Treated set | Posted | Number | participants | Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | AUC0-inf of Nintedanib | Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) | Pharmacokinetic (PK) set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Cmax of Nintedanib | Maximum measured concentration of nintedanib in plasma (Cmax) | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | AUC0-inf of Pemetrexed | Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Cmax of Pemetrexed | Maximum measured concentration of pemetrexed in plasma (Cmax) | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2 |
|
|
Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIBF 1120 100 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. | 1 | 3 | 3 | 3 | ||
| EG001 | BIBF 1120 150 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. | 0 | 6 | 6 | 6 | ||
| EG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. | 1 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Tri-iodothyronine free decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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The trial was planned to comprise of two parts, with the phase II being based on the results of another study. The other study was stopped early due to futility analysis therefore only phase I of the study was completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Male |
|
| OG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
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| OG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
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| OG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
|
|
| OG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
|
|
| OG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
|
|
| OG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
|
|
| OG002 | BIBF 1120 200 mg + Pemetrexed 500 mg/m^2 | Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses. |
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