Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005364-14 | EudraCT Number | EudraCT |
Not provided
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The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBF 1120 + mFolfox6 | Experimental | BIBF1120 medium dose twice daily |
|
| Bevacizumab + mFolfox6 | Active Comparator | Bevacizumab 5mg/kg once daily every other week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBF 1120 | Drug | BIBF 1120 100 and 150 mg capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate at 9 Months (PFS-9) | PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0).
| First treatment administration to nine months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time from first treatment until death. Greenwood variance was used for the calculation of 95% confidence interval. | First treatment administration until end of treatment, up to 892 days |
| Progression-free Survival (PFS) |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1199.51.32002 Boehringer Ingelheim Investigational Site | Bonheiden | Belgium | ||||
| 1199.51.32005 Boehringer Ingelheim Investigational Site |
Maximum Tolerable Dose set (MTD): The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study.
The patient randomised to MTD analysis set were in Phase-1. The final data base lock date for this study was 23 JUL 2013.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib 150 mg + mFolfox6 | Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion). |
| FG001 | Nintedanib 200 mg + mFolfox6 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BIBF 1120 |
| Drug |
BIBF 1120 100 and 150 mg capsules |
|
| mFolfox | Drug | standard i.v chemotherapy |
|
| Bevacizumab | Drug | 100 mg/Kg solution , IV infusion |
|
| mFolfox 6 | Drug | IV standard chemotherapy |
|
| bevacizumab | Drug | 100 mg/4 ml solution |
|
PFS is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death throughout the whole study. Progression is assessed according to RECIST criteria (version 1.0). In this endpoint, the Greenwood's variance estimate was used to calculate the Kaplan-Meier progression free survival median and its corresponding 95% confidence interval |
| First treatment administration until end of treatment, up to 892 days |
| Confirmed Objective Response Rate | Objective response rate is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% confidence interval represent the Clopper-Pearson exact confidence interval | First treatment administration until end of treatment, up to 892 days |
| Unconfirmed Objective Response Rate | Objective response is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% Confidence interval represent the Clopper- Pearson exact confidence interval. | First treatment administration until end of treatment, up to 892 days |
| Resection Rate | Surgical excision of the lesions is allowed if the previous assessment of tumoral response occurred after at least 6 cycles of treatment. Resection Rate includes resection rates R0, R1 and R2 before progressive disease. Peto's variance estimate was used. | First treatment administration until end of treatment, up to 892 days |
| Tumor Shrinkage | For each patient, the minimum percentage increase from baseline measurement (≤ 28 days before the beginning of the treatment) of the sum Longest diameter (LD) of target lesions was calculated based on the measurements of tumor size. The minimum percentage increase has been divided to four groups:
| Baseline and day 85 |
| Incidence and Intensity of Adverse Events With Grading According CTCAE | Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0). | From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days |
| Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I). | Percentage of patients with DLTs,AE were observed in Gastrointestinal,Hepatobiliary & skin and subcutaneous tissue disorder.Drug related DLT was defined:1)Gastrointestinal toxicity(vomiting, nausea and diarrhoea)or hypertension of CTCAEgrade(G)3 despite optimal supportive care/intervention.2)Non-haematological toxicity of G≥3 except AE:alopecia,nail modifications,& isolated elevation of gamma glutamyl transpeptidase.3)G4 neutropenia for>7days(not associated with fever≥38.5°C).4)Neutropenia of G≥3 of any duration associated with fever≥38.5ºC.5)Platelets <25,000/μLorG3 thrombocytopenia associated with bleeding requiring transfusion.6)Inability to resume nintedanib dosing within14days of stopping due to treatment related toxicity.7)ALT and/or AST elevation of G≥3orG≥2 in conjunction with bilirubin G>1. 8)Inability to recover from increase ALT/AST in conjunction with increase of bilirubin toALT/AST toG≤1 &bilirubin to normal or baseline within14days after nintedanib treatment interruption | First two treatment cycles, up to 28 days |
| Maximum Tolerable Dose (MTD) | Determination of Maximum Tolerable Dose based on DLT incidence. | First two treatment cycles, up to 28 days |
| Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I) | Area under the plasma concentration time-curve over 12 hours for Nintedanib in the dosing interval at steady state and normalized by the dosing unit administered (AUCtau,ss,norm) (Phase I) | -0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h and 10h after drug administration. |
| Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I) | Maximum plasma concentration for Nintedanib at steady state and normalized by the dosing unit administered (Cmax,ss,norm) (Phase I) | -0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h, and 10h after drug administration. |
| Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores. | Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 for the change from baseline at 9 months for Global health status scores. Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for Global health status scores | Baseline and 9 months. |
| Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months. | Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the change from baseline at 9 months for functional scales, Symptom scales Chemotherapy side effects . The EORTC-QLQ-CR38 was composed of functioning scales (body image, future perspective, sexual enjoyment, sexual functioning) and symptom scales (chemotherapy side effects, defecation problems, symptoms of the gastrointestinal tract, micturition problems,female sexual problems, male sexual problems, stoma related problems, and weight loss). Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for functional scales and a worse quality of life for symptom scales. | Baseline and 9 months. |
| Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag. | Number of participants for Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the first use of stoma bag. | from baseline until end of treatment, up to 892 days |
| Exploratory Biomarker and Pharmacogenetic Analysis for VEGF | Exploratory biomarker and pharmacogenetic analysis for Vascular endothelial growth factor (VEGF). Note: This endpoint was not statistically analysed in this study. | Day 1, Day 29, Day 57, Day 85 and Day 127 |
| Brussels |
| Belgium |
| 1199.51.32006 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1199.51.32001 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 1199.51.3306A Boehringer Ingelheim Investigational Site | Nice | France |
| 1199.51.3306B Boehringer Ingelheim Investigational Site | Nice | France |
| 1199.51.3306C Boehringer Ingelheim Investigational Site | Nice | France |
| 1199.51.3306D Boehringer Ingelheim Investigational Site | Nice | France |
| 1199.51.3301A Boehringer Ingelheim Investigational Site | Paris | France |
| 1199.51.3301B Boehringer Ingelheim Investigational Site | Paris | France |
| 1199.51.3301C Boehringer Ingelheim Investigational Site | Paris | France |
| 1199.51.3301D Boehringer Ingelheim Investigational Site | Paris | France |
| 1199.51.3307A Boehringer Ingelheim Investigational Site | Reims | France |
| 1199.51.3307B Boehringer Ingelheim Investigational Site | Reims | France |
| 1199.51.3307C Boehringer Ingelheim Investigational Site | Reims | France |
| 1199.51.3308A Boehringer Ingelheim Investigational Site | Saint-Herblain | France |
| 1199.51.3308B Boehringer Ingelheim Investigational Site | Saint-Herblain | France |
| 1199.51.3308C Boehringer Ingelheim Investigational Site | Saint-Herblain | France |
| 1199.51.3308D Boehringer Ingelheim Investigational Site | Saint-Herblain | France |
| 1199.51.3308E Boehringer Ingelheim Investigational Site | Saint-Herblain | France |
| 1199.51.3305A Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1199.51.3305B Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1199.51.3305C Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1199.51.3305D Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1199.51.3305E Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1199.51.3302A Boehringer Ingelheim Investigational Site | Villejuif | France |
| 1199.51.3302B Boehringer Ingelheim Investigational Site | Villejuif | France |
| 1199.51.3302C Boehringer Ingelheim Investigational Site | Villejuif | France |
| 1199.51.3302D Boehringer Ingelheim Investigational Site | Villejuif | France |
| 1199.51.3302E Boehringer Ingelheim Investigational Site | Villejuif | France |
| 1199.51.49001 Boehringer Ingelheim Investigational Site | Celle | Germany |
| 1199.51.49002 Boehringer Ingelheim Investigational Site | Dresden | Germany |
| 1199.51.49003 Boehringer Ingelheim Investigational Site | Freiburg/Breisgau | Germany |
| 1199.51.49004 Boehringer Ingelheim Investigational Site | Halle | Germany |
| 1199.51.49006 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1199.51.49008 Boehringer Ingelheim Investigational Site | Schwäbisch Hall | Germany |
| 1199.51.39002 Boehringer Ingelheim Investigational Site | Ancona | Italy |
| 1199.51.39001 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1199.51.39004 Boehringer Ingelheim Investigational Site | Province of Macerata | Italy |
| 1199.51.39005 Boehringer Ingelheim Investigational Site | Reggio Emilia | Italy |
| 1199.51.39003 Boehringer Ingelheim Investigational Site | Udine | Italy |
| 1199.51.34007 Boehringer Ingelheim Investigational Site | A Coruña | Spain |
| 1199.51.34006 Boehringer Ingelheim Investigational Site | Alicante | Spain |
| 1199.51.34005 Boehringer Ingelheim Investigational Site | Barakaldo | Spain |
| 1199.51.34001 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1199.51.34003 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1199.51.34004 Boehringer Ingelheim Investigational Site | Madrid | Spain |
Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion). |
| FG002 | Bevacizumab 5 mg + mFolfox6 (Phase II) | Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS) - The treated set includes all patients who were dispensed and were documented to have taken at least one dose of the trial drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib + mFolfox6 | Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion). |
| BG001 | Bevacizumab + mFolfox6 | Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion). |
| BG002 | 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 | Mean | Standard Deviation | 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 | Progression-free Survival Rate at 9 Months (PFS-9) | PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0).
| Treated Set (TS) - The treated set includes all patients who were dispensed and were documented to have taken at least one dose of the trial drug. | Posted | Number | 95% Confidence Interval | percentage of Participants | First treatment administration to nine months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time from first treatment until death. Greenwood variance was used for the calculation of 95% confidence interval. | Treated Set (TS). | Posted | Median | 95% Confidence Interval | months | First treatment administration until end of treatment, up to 892 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death throughout the whole study. Progression is assessed according to RECIST criteria (version 1.0). In this endpoint, the Greenwood's variance estimate was used to calculate the Kaplan-Meier progression free survival median and its corresponding 95% confidence interval | Treated Set (TS). | Posted | Median | 95% Confidence Interval | months | First treatment administration until end of treatment, up to 892 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirmed Objective Response Rate | Objective response rate is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% confidence interval represent the Clopper-Pearson exact confidence interval | Treated Set (TS). | Posted | Number | 95% Confidence Interval | percentage of Participants | First treatment administration until end of treatment, up to 892 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unconfirmed Objective Response Rate | Objective response is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% Confidence interval represent the Clopper- Pearson exact confidence interval. | Treated Set (TS). | Posted | Number | 95% Confidence Interval | percentage of Participants | First treatment administration until end of treatment, up to 892 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Resection Rate | Surgical excision of the lesions is allowed if the previous assessment of tumoral response occurred after at least 6 cycles of treatment. Resection Rate includes resection rates R0, R1 and R2 before progressive disease. Peto's variance estimate was used. | Treated Set (TS) | Posted | Number | 95% Confidence Interval | percentage of Participants | First treatment administration until end of treatment, up to 892 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Shrinkage | For each patient, the minimum percentage increase from baseline measurement (≤ 28 days before the beginning of the treatment) of the sum Longest diameter (LD) of target lesions was calculated based on the measurements of tumor size. The minimum percentage increase has been divided to four groups:
| Treated Set (TS) | Posted | Number | participants | Baseline and day 85 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence and Intensity of Adverse Events With Grading According CTCAE | Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0). | Treated Set (TS) | Posted | Number | participants | From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I). | Percentage of patients with DLTs,AE were observed in Gastrointestinal,Hepatobiliary & skin and subcutaneous tissue disorder.Drug related DLT was defined:1)Gastrointestinal toxicity(vomiting, nausea and diarrhoea)or hypertension of CTCAEgrade(G)3 despite optimal supportive care/intervention.2)Non-haematological toxicity of G≥3 except AE:alopecia,nail modifications,& isolated elevation of gamma glutamyl transpeptidase.3)G4 neutropenia for>7days(not associated with fever≥38.5°C).4)Neutropenia of G≥3 of any duration associated with fever≥38.5ºC.5)Platelets <25,000/μLorG3 thrombocytopenia associated with bleeding requiring transfusion.6)Inability to resume nintedanib dosing within14days of stopping due to treatment related toxicity.7)ALT and/or AST elevation of G≥3orG≥2 in conjunction with bilirubin G>1. 8)Inability to recover from increase ALT/AST in conjunction with increase of bilirubin toALT/AST toG≤1 &bilirubin to normal or baseline within14days after nintedanib treatment interruption | MTD set: The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study. The outputs (updated with cleaned and more complete data) that were used to decide on the MTD of nintedanib while the study was ongoing. | Posted | Number | percentage of participants | First two treatment cycles, up to 28 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Tolerable Dose (MTD) | Determination of Maximum Tolerable Dose based on DLT incidence. | MTD Set | Posted | Number | mg | First two treatment cycles, up to 28 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I) | Area under the plasma concentration time-curve over 12 hours for Nintedanib in the dosing interval at steady state and normalized by the dosing unit administered (AUCtau,ss,norm) (Phase I) | Treated Set (TS). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL/mg | -0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h and 10h after drug administration. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I) | Maximum plasma concentration for Nintedanib at steady state and normalized by the dosing unit administered (Cmax,ss,norm) (Phase I) | Treated Set (TS). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | -0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h, and 10h after drug administration. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores. | Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 for the change from baseline at 9 months for Global health status scores. Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for Global health status scores | Treated Set (TS). Number of analysed patients are the total number of patients who were analysed for the change from baseline at 9 months for Global health status scores | Posted | Mean | Standard Deviation | units on scale | Baseline and 9 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months. | Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the change from baseline at 9 months for functional scales, Symptom scales Chemotherapy side effects . The EORTC-QLQ-CR38 was composed of functioning scales (body image, future perspective, sexual enjoyment, sexual functioning) and symptom scales (chemotherapy side effects, defecation problems, symptoms of the gastrointestinal tract, micturition problems,female sexual problems, male sexual problems, stoma related problems, and weight loss). Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for functional scales and a worse quality of life for symptom scales. | Treated Set (TS) | Posted | Mean | Standard Deviation | units on scale | Baseline and 9 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag. | Number of participants for Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the first use of stoma bag. | Treated Set (TS). | Posted | Number | participants | from baseline until end of treatment, up to 892 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Exploratory Biomarker and Pharmacogenetic Analysis for VEGF | Exploratory biomarker and pharmacogenetic analysis for Vascular endothelial growth factor (VEGF). Note: This endpoint was not statistically analysed in this study. | Not Posted | Day 1, Day 29, Day 57, Day 85 and Day 127 |
From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nintedanib + mFolfox6 | Patients receiving nintedanib 150 mg or 200 mg twice daily plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion). | 31 | 85 | 84 | 85 | ||
| EG001 | Bevacizumab + mFolfox6 | Patients receiving bevacizumab 5 mg/kg every other week plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion) | 22 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Prosthesis implantation | Surgical and medical procedures | MEDDRA 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
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 Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
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| OG001 | Nintedanib 200 mg + mFolfox6 (Phase I) | Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion). |
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| Participants |
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