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This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Participants will receive bevacizumab in combination with capecitabine and oxaliplatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab administered according to prescribing information and normal clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions. | From randomization to progression or death during the study (up to approximately 30 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (Tumor Assessments According to RECIST) | Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine and oxaliplatin.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banská Bystrica | 975 17 | Slovakia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Capecitabine | Biological | Capecitabine administered according to prescribing information and normal clinical practice. |
|
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| Oxaliplatin | Drug | Capecitabine administered according to prescribing information and normal clinical practice. |
|
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| Up to approximately 30 months |
| Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to approximately 30 months |
| Bratislava |
| 812 50 |
| Slovakia |
| Bratislava | 833 10 | Slovakia |
| Košice | 04001 | Slovakia |
| Martin | 036 59 | Slovakia |
| Nitra | 950 01 | Slovakia |
| Poprad | 058 01 | Slovakia |
| Prešov | 081 81 | Slovakia |
| Ružomberok | 03426 | Slovakia |
| Included in Final Analysis |
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| Evaluable for Primary Endpoint Analysis |
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| COMPLETED |
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| NOT COMPLETED |
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Includes enrolled participants eligible for inclusion in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice. |
| 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 |
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| 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 | Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions. | Includes enrolled participants who were evaluable for the primary endpoint analysis. | Posted | Median | 95% Confidence Interval | months | From randomization to progression or death during the study (up to approximately 30 months) |
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| |||||||||||||||||||||||||
| Secondary | Response Rate (Tumor Assessments According to RECIST) | Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR | Includes enrolled participants who were evaluable for the primary endpoint analysis. | Posted | Number | percentage of participants | Up to approximately 30 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Includes enrolled participants eligible for inclusion in the final analysis. | Posted | Number | percentage of participants | Up to approximately 30 months |
|
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Up to approximately 30 months
Includes enrolled participants eligible for inclusion in the final analysis.
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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 | Bevacizumab | Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice. | 2 | 63 | 39 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive crisis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Allergic reaction | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.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 |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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