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The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Colorectal Cancer | Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab + Chemotherapy | Other | Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Panitumumab Infusions | 12 months | |
| Cumulative Dose of Panitumumab | 12 months | |
| Maximum Dose of Panitumumab | 12 months | |
| Duration of Panitumumab Exposure | Duration of exposure is the time from the first to the last panitumumab infusion | 12 months |
| Mean Interval Between Panitumumab Infusions | 12 months | |
| Percentage of Participants With at Least One Panitumumab Dose Reduction | 12 months | |
| Percentage of Participants With at Least One Panitumumab Dose Delay | 12 months | |
| Reasons for Discontinuation of Panitumumab | 12 months | |
| Duration of Exposure of All Concomitant Chemotherapy | Duration of exposure is the time from the first date to the last date of chemotherapy administration. | 12 months |
| Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Hospitalization | 12 months | |
| Types of Hospital Visit | Participants may have had more than one type of hospital visit. | 12 months |
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Inclusion Criteria
Exclusion Criteria
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All treatment centres (inpatient and outpatient) with a focus on treating patients with mCRC. Centres will be selected to represent academic, oncology and specialist settings and to provide geographical diversity in France and Germany.
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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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The study was conducted in France and Germany between 10 December 2012 and 30 November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab + FOLFOX First-line | Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS). |
| FG001 | Panitumumab + FOLFIRI Second-line | Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS). |
| FG002 | Panitumumab + FOLFIRI First-line | Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab + FOLFOX First-line | Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS). |
| BG001 | Panitumumab + FOLFIRI Second-line |
| 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 | Total Number of Panitumumab Infusions | Posted | Median | Inter-Quartile Range | infusions | 12 months |
|
From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively.
Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 + FOLFOX First-line | Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal 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 |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay | 12 months |
| Duration of Hospital Stay | 12 months |
| Reasons for Hospitalization | Participants may have had more than one hospital visit and/or reason for a hospital visit. | 12 months |
| Percentage of Participants With an Overall Response | Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST). | 12 months |
| Number of Participants With Resectability | Resectability denotes whether a participant became resectable during the study. | 12 months |
| Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation | 12 months |
| Type of Post-Panitumumab Anti-cancer Treatment | Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation. | 12 months |
| Lost to Follow-up |
|
| Administrative Decision |
|
| Withdrawal by Subject |
|
Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS). |
| BG002 | Panitumumab + FOLFIRI First-line | Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | Count of Participants | Participants |
|
| Primary Colorectal Cancer Type | Count of Participants | Participants |
|
| Metastatic Colorectal Cancer Status | Synchronous colorectal neoplasias are defined as 2 or more primary tumors identified in the same patient and at the same time. Metachronous refers to lesions that appear after diagnosis of the primary lesion. | Count of Participants | Participants |
|
| Metastatic Disease Lesion Sites | Number | participants |
|
Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS). |
|
|
| Primary | Cumulative Dose of Panitumumab | Posted | Median | Inter-Quartile Range | mg | 12 months |
|
|
|
| Primary | Maximum Dose of Panitumumab | Posted | Median | Inter-Quartile Range | mg | 12 months |
|
|
|
| Primary | Duration of Panitumumab Exposure | Duration of exposure is the time from the first to the last panitumumab infusion | Posted | Median | Inter-Quartile Range | months | 12 months |
|
|
|
| Primary | Mean Interval Between Panitumumab Infusions | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Percentage of Participants With at Least One Panitumumab Dose Reduction | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Primary | Percentage of Participants With at Least One Panitumumab Dose Delay | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Primary | Reasons for Discontinuation of Panitumumab | Participants who discontinued panitumumab while on study | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Duration of Exposure of All Concomitant Chemotherapy | Duration of exposure is the time from the first date to the last date of chemotherapy administration. | Posted | Median | Inter-Quartile Range | months | 12 months |
|
|
|
| Primary | Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction | Posted | Number | percentage of participants | 12 months |
|
|
|
| Primary | Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay | Posted | Number | percentage of participants | 12 months |
|
|
|
| Secondary | Number of Participants With at Least One Hospitalization | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Types of Hospital Visit | Participants may have had more than one type of hospital visit. | Participants with at least one hospital visit | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Duration of Hospital Stay | Participants with at least one hospital visit | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
|
| Secondary | Reasons for Hospitalization | Participants may have had more than one hospital visit and/or reason for a hospital visit. | Participants with at least one hospitalization | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Percentage of Participants With an Overall Response | Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST). | Participants with tumor response data post-baseline | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Secondary | Number of Participants With Resectability | Resectability denotes whether a participant became resectable during the study. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Type of Post-Panitumumab Anti-cancer Treatment | Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation. | Participants who reported use of anti-cancer treatment after discontinuation of panitumumab | Posted | Number | participants | 12 months |
|
|
|
| 0 |
| 164 |
| 10 |
| 164 |
| 101 |
| 164 |
| EG001 | Panitumumab + FOLFIRI Second-line | Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS). | 0 | 37 | 0 | 37 | 25 | 37 |
| EG002 | Panitumumab + FOLFIRI First-line | Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS). | 0 | 12 | 0 | 12 | 8 | 12 |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Inflammation of wound | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Eastern Cooperative Oncology Group performance status worsened | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Collapse circulatory | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 19.0 | 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.
| D009369 | Neoplasms |
| 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 |
| D013812 | Therapeutics |
| > 14 to 21 days |
|
| > 21 to 28 days |
|
| > 28 days |
|
| Planned surgical resection |
|
| Death |
|
| Adverse Drug Reaction (ADR) |
|
| Patient request to discontinue all treatment |
|
| Adverse event |
|
| Lost to follow-up |
|
| Other |
|
| Patient request to discontinue panitumumab |
|
| Title | Measurements |
|---|---|
|
| Emergency room |
|
| Day case |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| mCRC and treatment related |
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| Radiotherapy |
|
| Targeted biologics |
|
| Other small molecules |
|