Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022270-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this protocol is to allow continued treatment with conatumumab and/or ganitumab, with or without chemotherapy, to participants who completed a separate Amgen-sponsored conatumumab or ganitumab study without disease progression whose previous studies were closed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conatumumab Monotherapy | Experimental | Participants will continue to receive conatumumab every 2 weeks (Q2W) or every 3 weeks (Q3W) at the same dose and regimen as at the conclusion of the parent study. |
|
| Conatumumab + Ganitumab | Experimental | Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study. |
|
| Ganitumab Monotherapy | Experimental | Participants will continue to receive ganitumab Q3W or every 4 weeks (Q4W) at the same dose and regimen as at the conclusion of the parent study. |
|
| Conatumumab + mFOLFOX6 ± Bevacizumab | Experimental | Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified FOLFOX6 | Drug | The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| Number of Participants With Serious Adverse Events | A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:
| From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change From Baseline in Blood Pressure | Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits. | Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
Not provided
Inclusion Criteria:
Subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
This was an extension study that permitted participants to continue treatment with conatumumab, with or without co-therapy (modified FOLFOX6 chemotherapy with or without bevacizumab, or ganitumab), or with ganitumab alone, administered at the same dose level and schedule that participants received at the conclusion of the parent study. Participants remained on treatment until disease progression, intolerability, or withdrawal of consent.
Results are reported by parent study and treatment.
This study enrolled participants with different types of solid tumors who had completed one of the following Amgen-sponsored conatumumab or ganitumab studies:
20050118 (NCT00562380) 20050171 20060295 (NCT00534027) 20060340 (NCT00791011) 20060464 (NCT00625651) 20070411 (NCT00819169). Participants who had not progressed in the parent study were eligible to participate in this trial.
The study was conducted at 12 centers in the United States, Spain, and Poland.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 20050118: Ganitumab 20 mg/kg | Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion. |
| FG001 | 20050171: Conatumumab 0.45 mg/kg | Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2017 | Feb 3, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Conatumumab | Biological | Administered by intravenous infusion Q2W or Q3W. |
|
|
| Ganitumab | Biological | Administered by intravenous infusion Q3W or Q4W. |
|
|
| Bevacizumab | Biological | Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle. |
|
|
| Minimum Change From Baseline in Blood Pressure | Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits. | Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| Best Overall Response | Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease. | Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| Number of Participants With Disease Progression or Death Due to Disease Progression | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| La Jolla |
| California |
| 92093-0957 |
| United States |
| Research Site | Denver | Colorado | 80218 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Buffalo | New York | 14263 | United States |
| Research Site | Memphis | Tennessee | 38120 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Ogden | Utah | 84403 | United States |
| Research Site | Szczecin | 70-891 | Poland |
| Research Site | Barcelona | Catalonia | 08035 | Spain |
| FG002 | 20060295: Conatumumab 3 mg/kg | Conatumumab 3 mg/kg every 3 weeks by intravenous infusion. |
| FG003 | 20060340: Conatumumab 5 mg/kg | Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion. |
| FG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 (mFOLFOX6) chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| FG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| FG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who received at least one dose of conatumumab or ganitumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 20050118: Ganitumab 20 mg/kg | Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion. |
| BG001 | 20050171: Conatumumab 0.45 mg/kg | Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion. |
| BG002 | 20060295: Conatumumab 3 mg/kg | Conatumumab 3 mg/kg every 3 weeks by intravenous infusion. |
| BG003 | 20060340: Conatumumab 5 mg/kg | Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion. |
| BG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| BG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| BG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
| BG007 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Adverse Events | An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. | Participants who received at least one dose of conatumumab or ganitumab. | Posted | Count of Participants | Participants | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events | A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:
| Participants who received at least one dose of conatumumab or ganitumab. | Posted | Count of Participants | Participants | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Change From Baseline in Blood Pressure | Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits. | Participants who received at least one dose of conatumumab or ganitumab. | Posted | Mean | Standard Deviation | mmHg | Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Change From Baseline in Blood Pressure | Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits. | Participants who received at least one dose of conatumumab or ganitumab. | Posted | Mean | Standard Deviation | mmHg | Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | Participants who received at least one dose of conatumumab or ganitumab. | Posted | Count of Participants | Participants | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response | Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease. | Participants who received at least one dose of conatumumab or ganitumab. | Posted | Count of Participants | Participants | Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Disease Progression or Death Due to Disease Progression | Participants who received at least one dose of conatumumab or ganitumab. | Posted | Count of Participants | Participants | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. |
|
From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
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 | 20050118: Ganitumab 20 mg/kg | Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG001 | 20050171: Conatumumab 0.45 mg/kg | Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | 20060295: Conatumumab 3 mg/kg | Conatumumab 3 mg/kg every 3 weeks by intravenous infusion. | 0 | 1 | 1 | 1 | 1 | 1 |
| EG003 | 20060340: Conatumumab 5 mg/kg | Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. | 0 | 3 | 3 | 3 | 3 | 3 |
| EG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. | 0 | 2 | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Transurethral bladder resection | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac flutter | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Eyelid infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Anticoagulation drug level above therapeutic | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood magnesium increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood testosterone decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| White blood cells urine | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vaginal odour | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Micrographic skin surgery | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| May-Thurner syndrome | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2010 | Feb 3, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002276 | Carcinoid Tumor |
| D015179 | Colorectal Neoplasms |
| D008223 | Lymphoma |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C554537 | conatumumab |
| C545764 | ganitumab |
| 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
| 65 - 74 years |
|
| 75 - 84 years |
|
| ≥ 85 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| 20060340: Conatumumab 5 mg/kg |
Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion. |
| OG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| OG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| OG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg and ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
|
|
| OG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| OG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| OG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
|
|
| OG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| OG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| OG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
|
|
| OG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| OG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| OG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
|
|
| 20060340: Conatumumab 5 mg/kg |
Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion. |
| OG004 | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| OG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| OG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
|
|
Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. |
| OG005 | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. |
| OG006 | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. |
|
|