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This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants With Serious and Specific Adverse Events | A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Overall Survival | Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival. | Up to approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belo Horizonte | 30140-083 | Brazil | ||||
168 participants were enrolled in the study of which 162 received at least one dose of study drug. Only those who received at least one dose of study medication were included in the Intent to Treat (ITT) population, which is the population reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Fluoropyrimidine-based Chemotherapy | Drug | Fluoropyrimidine-based chemotherapy administered according to standard of care. |
|
| Efficacy: Time to Disease Progression |
Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression. |
| Up to approximately 3 years |
| Efficacy: Progression-free Survival | Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS. | Up to approximately 3 years |
| Belo Horizonte |
| 30150-221 |
| Brazil |
| Belo Horizonte | 30150321 | Brazil |
| BrasÃlia | 70390-150 | Brazil |
| BrasÃlia | 70710-904 | Brazil |
| Campinas | 13073-400 | Brazil |
| Campinas | 13084-759 | Brazil |
| Caxias do Sul | 95020-450 | Brazil |
| Curitiba | 80530-010 | Brazil |
| Curitiba | 80730-180 | Brazil |
| Fortaleza | 60741-420 | Brazil |
| Ijuà | 98700-000 | Brazil |
| João Pessoa | 58040280 | Brazil |
| Porto Alegre | 90020-090 | Brazil |
| Porto Alegre | 90035-903 | Brazil |
| Recife | 52012-220 | Brazil |
| Ribeirão Preto | 14025-430 | Brazil |
| Rio de Janeiro | 22031072 | Brazil |
| Rio de Janeiro | 22631-004 | Brazil |
| Salvador | 40170-110 | Brazil |
| Salvador | 41810-012 | Brazil |
| Salvador | 41950-610 | Brazil |
| São Paulo | 01229-000 | Brazil |
| São Paulo | 01232-010 | Brazil |
| São Paulo | 01332-000 | Brazil |
| São Paulo | 01406100 | Brazil |
| São Paulo | 04122-000 | Brazil |
| São Paulo | 05651-901 | Brazil |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent to treat (ITT) population included all participants receiving at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion. |
| 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 |
| |||||||||||||||||
| Gender | 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 | Safety: Number of Participants With Serious and Specific Adverse Events | A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction. | The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information. | Posted | Number | participants | Up to approximately 3 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Overall Survival | Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival. | 158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Time to Disease Progression | Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression. | 158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Progression-free Survival | Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS. | 158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
|
Up to approximately 3 years
The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was used for the reporting of safety information.
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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 | Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion. | 50 | 162 | 153 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Genitourinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Immunodeficiency | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Vaginal fistula | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
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 |
| 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 |
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| Title | Measurements |
|---|---|
|
| Spec AEs: Proteinuria |
|
| Spec AEs:Wound healing complications |
|
| Spec AEs: Thrombosis/thrombus/embolism |
|
| Spec AEs: T/t/e - Vascular Access |
|
| Spec AEs: Gastrointestinal perforation |
|
| Spec AEs: Infusion (injection) Site Reaction |
|
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