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This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 15mg/kg iv every 3 weeks |
| |
| Interferon alfa-2a |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression or Death | Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. | Days 0, 91, 182, 273, 365, 456, and 547 |
| PFS - Time to Event | PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method | Days 0, 91, 182, 273, 365, 456, and 547 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST. | Baseline and Cycles 3, 6, 9, 13, and 17 |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 10117 | Germany | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine | Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3). Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression. If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Bevacizumab + IFN/Vinblastine |
|
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| Drug |
3 MioIU sc escalating to 18 MioIU sc, 3 times weekly |
|
| Vinblastine | Drug | 0.1mg/kg iv every 3 weeks |
|
OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points. |
| Baseline, Day 1 of every cycle to disease progression or death (up to Week 102) |
| Berlin |
| 10967 |
| Germany |
| Bremen | 28277 | Germany |
| Dessau | 06846 | Germany |
| Erlangen | 91052 | Germany |
| Frankfurt | 60596 | Germany |
| Halle | 06097 | Germany |
| Hanover | 30449 | Germany |
| Jena | 07743 | Germany |
| Kassel | 34125 | Germany |
| Kiel | 24105 | Germany |
| Leipzig | 04103 | Germany |
| Magdeburg | 39120 | Germany |
| Rehling | 86058 | Germany |
| Stuttgart | 70174 | Germany |
| Weiden | 92637 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Bevacizumab Monotherapy |
|
|
Safety Population: included all participants, even those who withdrew from the study prematurely and who received at least 1 dose of bevacizumab and had a safety follow-up visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + IFN/Vinblastine | Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3). Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression. If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression. |
| 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 | Percentage of Participants With Disease Progression or Death | Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. | Intent-to-treat (ITT) population: all participants, even those who withdrew from the study prematurely, who received at least 1 dose of study medication and for whom the primary efficacy variable was measured at least once during the time when the participant received study medication. | Posted | Number | percentage of participants | Days 0, 91, 182, 273, 365, 456, and 547 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST. | ITT Population; missing data were imputed using the last observation carried forward (LOCF) technique. Number (n) equals (=) number of participants assessed at each specific visit. | Posted | Number | percentage of participants | Baseline and Cycles 3, 6, 9, 13, and 17 |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points. | Two of 25 participants died during the course of the study, thus, median overall survival could not be analyzed. | Posted | Median | Full Range | weeks | Baseline, Day 1 of every cycle to disease progression or death (up to Week 102) |
|
| ||||||||||||||||||||||||||
| Primary | PFS - Time to Event | PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method | ITT population. | Posted | Median | Standard Error | days | Days 0, 91, 182, 273, 365, 456, and 547 |
|
|
From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
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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 + IFN/Vinblastine | Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3). Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression. If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression. | 8 | 25 | 22 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Intraocular pressure test | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fascial hernia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-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-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077190 | Interferon alpha-2 |
| D014747 | Vinblastine |
| 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 |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Participants |
|
|
|
|
|
|