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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004722-25 | EudraCT Number |
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This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.
This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.
The objective for Part 1 is to identify a tolerable dose of conatumumab in combination with panitumumab based on the incidence of dose-limiting toxicities in patients with Metastatic Colorectal Cancer.
The objective for Part 2 is to evaluate the objective response rate stratified by Kirsten Rat Sarcoma Virus Oncogene (KRAS) status (wild-type versus mutant) in patients with Metastatic Colorectal Cancer treated with the combination of panitumumab and conatumumab (tolerable dose identified in part 1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab plus conatumumab | Experimental | Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Administered by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Dose-limiting Toxicities | A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities. | 4 weeks |
| Number of Participants With an Objective Response | An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions. |
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Inclusion Criteria:
Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
Radiographically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) during or following treatment with fluoropyrimidine, irinotecan, and/or oxaliplatin chemotherapy for Metastatic Colorectal Cancer. Progressive disease must be documented during or ≤ 6 months after the last dose of the most recent chemotherapy regimen prior to enrollment.
At least 1 uni-dimensionally measurable lesion measuring ≥ 20 mm in one dimension per modified RECIST. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to enrollment. All sites of disease must be evaluated.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Available archived paraffin-embedded tumor tissue from the primary tumor or metastasis for submission to the central laboratory
Man or woman ≥ 18 years of age at the time of enrollment
Hematologic function within the following limits:
Renal function within the following limits:
Hepatic function within the following limits:
Metabolic function within the following limits:
Negative pregnancy test ≤ 72 hours before enrollment (for woman of childbearing potential only)
Must have received 1, 2, or 3 prior chemotherapy regimens for Metastatic Colorectal Cancer
Competent to comprehend, sign, and date the independent ethics committee/institutional review board (IEC/IRB) approved written informed consent
Exclusion Criteria:
History of other primary cancer, unless:
Prior treatment with anti-epidermal growth factor receptor (EGFr) inhibitors (eg, cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant setting ≥ 6 months before enrollment
Use of systemic chemotherapy and radiotherapy ≤ 30 days before enrollment
Use of prior anti-tumor therapies with a short serum half-life (less than 1 week) including prior experimental agents or approved anti-tumor small molecules ≤ 30 days before enrollment
Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab) including prior experimental or approved protein/antibodies ≤ 42 days before enrollment
Any investigational agent or therapy ≤ 30 days before enrollment
Known allergy or hypersensitivity to any component of panitumumab and/or AMG 655
History of or known presence of central nervous system (CNS) metastases
History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as ≥ Common Terminology Criteria for Adverse Events [CTCAE] grade 2 [CTCAE version 3.0])
Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion)
Any uncontrolled concurrent illness (eg, infection, bleeding) or history of any medical condition that may interfere with the interpretation of the study results
Major surgical procedure (requiring general anesthesia) ≤ 28 days or minor surgical procedure (excluding central venous catheter placement) ≤ 14 days before enrollment. Patients must have recovered from surgery related toxicities.
Other investigational procedures are excluded
Patient is currently pregnant or breast feeding
Man or woman of childbearing potential who is not willing to use adequate contraceptive precautions during treatment and for 6 months (for women) or 1 month (for men) after the last investigational product administration. Adequate contraceptive precautions includes double barrier contraceptive methods (eg, diaphragm and condom) or abstinence.
Previously enrolled into this study
Patient unwilling or unable to comply with study requirements
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 12 January 2008 through 6 November 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Wild-type KRAS | Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. |
| FG001 | Mutant KRAS | Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. |
| FG002 | Unknown KRAS | Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wild-type KRAS | Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Part 1: Number of Participants With Dose-limiting Toxicities | A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities. | DLT-evaluable patients were those who received ≥ 2 doses of panitumumab and conatumumab as scheduled (ie, weeks 1 and 3) and completed 4 weeks (28 days) of treatment, or had a DLT within the first 4 weeks (28 days) of treatment. | Posted | Number | participants | 4 weeks |
|
From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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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 | Panitumumab + AMG 655 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| C554537 | conatumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Conatumumab | Drug | Administered by intravenous infusion |
|
|
| Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
| Overall Survival | Kaplan-Meier estimate of time from enrollment to death from any cause | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
| Number of Participants With Disease Control | Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started. | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
| Time to Response | The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response. | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
| Duation of Response | The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response. | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
| Number of Participants With Anti-therapeutic Antibodies | Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay. | Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks. |
| Number of Participants With Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following:
| From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. |
| Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal. | From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. |
| Lost to Follow-up |
|
| Other |
|
| Mutant KRAS |
Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. |
| BG002 | Unknown KRAS | Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
| Primary | Number of Participants With an Objective Response | An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. | Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status and Baseline measurable disease. | Posted | Number | participants | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
|
|
|
| Secondary | Progression-free Survival | Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions. | Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. | Posted | Median | 95% Confidence Interval | weeks | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
|
|
|
| Secondary | Overall Survival | Kaplan-Meier estimate of time from enrollment to death from any cause | Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. | Posted | Median | 95% Confidence Interval | months | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
|
|
|
| Secondary | Number of Participants With Disease Control | Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started. | Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. | Posted | Number | participants | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
|
|
|
| Secondary | Time to Response | The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response. | Patients with an overall objective response | Posted | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
|
|
| Secondary | Duation of Response | The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response. | Patients with an overall objective response | Posted | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). |
|
|
| Secondary | Number of Participants With Anti-therapeutic Antibodies | Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay. | Safety analysis set, including all randomized patients who received at least 1 dose of investigational product. N indicates the number of patients with immunoassay results at the specified time points. | Posted | Number | participants | Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks. |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following:
| Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug. | Posted | Number | participants | From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. |
|
|
|
| Secondary | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal. | Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug. | Posted | Number | participants | From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. |
|
|
|
| 26 |
| 52 |
| 51 |
| 52 |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Biliary dilatation | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Growth of eyelashes | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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.
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Anti-conatumumab Antibody Post-baseline (N=37) |
|
| Title | Measurements |
|---|---|
|
| Grade 5 adverse event |
|
| Title | Measurements |
|---|---|
|
| Aspartate Amino Transferase increase |
|
| Bicarbonate decrease |
|
| Calcium increase |
|
| Calcium decrease |
|
| Glucose increase |
|
| Lipase increase |
|
| Magnesium decrease |
|
| Magnesium increase |
|
| Phosphorus decrease |
|
| Sodium decrease |
|
| Total Bilirubin increase |
|
| Absolute Neutrophil Count decrease |
|
| Hemoglobin decrease |
|
| Lymphocytes decrease |
|