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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITT-PTS: Personalized Treatment Strategy (Immuno-oncology) | Experimental | For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology included PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations per megabase, and/or Epstein-Barr virus positive. These patients received standard cytotherapy plus Nivolumab. |
|
| ITT-PTS: Personalized Treatment Strategy (HER2 amplified) | Experimental | HER2 amplified. These patients received standard cytotherapy plus Trastuzumab. |
|
| ITT-PTS: Personalized Treatment Strategy (EFGR amplified) | Experimental | EGFR amplified. These patients received ABT-806. |
|
| ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified) | Experimental | FGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab. |
|
| ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from enrollment to death from any cause. | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Biopsies Leading to an Adverse Event | Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis). | 1 Month |
| Completion of Biopsy and Successful, Molecularly-based Treatment Assignment |
| Measure | Description | Time Frame |
|---|---|---|
| First-line Progression-free Survival | Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Up to 60 Months |
Inclusion Criteria:
Histologically confirmed metastatic gastric or esophagogastric junction (type I,II,III Siewert) adenocarcinoma
Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery
Measurable metastatic disease by RECIST criteria,
ECOG PS 0,1
Age > 18 years
Patients must have normal organ and marrow function as defined below:
Consent to baseline metastatic and progressive disease biopsy (of metastatic/progressing lesion) for enabling biomarker assessment and treatment assignment (at each time point - baseline, PD1, PD2, PD3) as well as for correlative studies.
• Consent to baseline and serial blood draws for plasma/serum/whole blood banking for correlative studies
Ability to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed PANGEA treatment with first, second and third line therapy as tolerated.
Ability to comply with requirements of the protocol, as assessed by the investigator by the patient signing the consent form.
If history of exposure to anthracyclines during perioperative treatment, the following cumulative doses of anthracyclines must be less than:
Epirubicin < 720 mg/m2 Doxorubicin or liposomal doxorubicin < 360 mg/m2 Mitoxantrone > 120 mg/m2 and idarubicin > 90 mg/m2 If more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.
Cardiac Ejection Fraction >50% (for HER2+ patients) as assessed by echocardiogram, MUGA scan, or cardiac MRI
Willingness to use effective and reliable methods of contraception (For appropriate methods of contraception considered acceptable see Appendix B).
Both men and women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Catenacci, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ITT-PTS: Personalized Treatment Strategy | For patients with monoclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab. HER2 amplified patients received standard cytotherapy plus Trastuzumab. EGFR amplified patients received standard cytotherapy plus ABT-806 FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab. MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab. EGFR expressing patients received standard cytotherapy plus ABT 806. All negative patients received standard cytotherapy plus Ramucirumab. Of note, while the protocol section describes these tailored therapies, the efficacy evaluation was based on pooling these treatments into a combined "personalized treatment strategy" group and comparing with historical controls. Therefore this "arm" includes all such patients with monoclonal antibodies available. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2018 |
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MAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab. |
|
| ITT-PTS: Personalized Treatment Strategy (EGFR expressing) | Experimental | EGFR expressing. These patients received standard cytotherapy plus ABT 806. |
|
| ITT-PTS: Personalized Treatment Strategy (All negative) | Experimental | All negative. These patients received standard cytotherapy plus Ramucirumab. |
|
| Non-ITT: Standard Therapy | Other | Patients without monoclonal antibodies available received standard cytotherapy. |
|
| ABT-806 | Drug | ABT-806 |
|
| Bemarituzumab | Drug | Bemarituzumab |
|
| Ramucirumab | Drug | Ramucirumab |
|
|
| Nivolumab | Drug | Nivolumab |
|
|
| Standard cytotherapy | Drug | FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) |
|
Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). |
| Up to 1 month |
| Adverse Event From Serial Biopsy for Second-line Treatment | Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis) | Up to 60 Months |
| Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment | Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | Up to 60 months |
| Adverse Event From Serial Biopsy for Third-line Treatment | Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis) | Up to 60 months |
| Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment | Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | Up to 60 months |
| Objective Response to First Line Therapy | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 6 months |
| FG001 | Non-ITT: Standard Therapy | For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) Of note, this arm includes patients without monoclonal antibodies available, for whom no personalized treatment strategy was available. The intent of the protocol was NOT to compare this arm with arm 1. |
| Immuno-oncology |
|
| HER2 Amplified |
|
| EGFR Amplified |
|
| FGFR2 Amplified |
|
| MAPK/PIK3CA Aberrant |
|
| EGFR Expressing |
|
| All Negative |
|
| Other (Non-ITT) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ITT-PTS: Personalized Treatment Strategy | For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive patients received standard cytoptherapy plus Nivolumab HER2 amplified patients received standard cytotherapy plus Trastuzumab EGFR amplified patients received standard cytotherapy plus ABT-806 FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab. EGFR expressing patients received standard cytotherapy plus ABT 806. All negative patients received standard cytotherapy plus Ramucirumab. |
| BG001 | Non-ITT: Standard Therapy | For patients without monoclonal antibodies available, therapy was standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) |
| BG002 | 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Overall Survival | Time from enrollment to death from any cause. | Posted | Median | 95% Confidence Interval | months | Up to 60 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Biopsies Leading to an Adverse Event | Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis). | Unit of analysis is the biopsy. Each patient had two biopsies, one of the primary tumor and one of a metastatic site. | Posted | Number | biopsies | 1 Month | Biopsies | Biopsies |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Completion of Biopsy and Successful, Molecularly-based Treatment Assignment | Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | Unit of analysis is the biopsy. Two biopsies were performed per patient, one of the primary tumor and one from a metastatic site. | Posted | Number | biopsies | Up to 1 month | Biopsies | Biopsies |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Event From Serial Biopsy for Second-line Treatment | Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis) | This includes subset of patients administered second-line treatment | Posted | Count of Participants | Participants | Up to 60 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment | Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | This includes subset of patients administered second-line treatment | Posted | Count of Participants | Participants | Up to 60 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Event From Serial Biopsy for Third-line Treatment | Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis) | This includes subset of patients administered third-line treatment | Posted | Count of Participants | Participants | Up to 60 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment | Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS). | This includes subset of patients administered third-line treatment | Posted | Count of Participants | Participants | Up to 60 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | First-line Progression-free Survival | Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Median | 95% Confidence Interval | months | Up to 60 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Objective Response to First Line Therapy | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Count of Participants | Participants | Up to 6 months |
|
60 months
Molecular arms/groups are combined for this analysis because the intent of the study was to compare the overall strategy of molecular-based treatment vs. not undertaking molecular-based therapy. Thus the number of patients with adverse events over the potential three lines of therapy is reported.
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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 | ITT-PTS: Personalized Treatment Strategy | For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab. HER2 amplified patients received standard cytotherapy plus Trastuzumab. EGFR amplified patients received standard cytotherapy plus ABT-806.. FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab. MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab. EGFR expressing patients received standard cytotherapy plus ABT 806. All negative patients received standard cytotherapy plus Ramucirumab. | 56 | 68 | 29 | 68 | 68 | 68 |
| EG001 | Non-ITT: Standard Therapy | For patients without monoclonal antibodies available.These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) | 11 | 12 | 8 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal perforation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroparesis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distenstion | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest pain - cardiac | Congenital, familial and genetic disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizzines | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Facial pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroesophagial reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| General disorders and administration site conditions - Other | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Leukocytosis | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mood aleration - depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia synrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreases | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary track infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Catenacci, MD | University of Chicago | 2-1000 | dcatenac@bsd.uchicago.edu |
| Jan 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| C000604456 | depatuxizumab |
| C000714767 | bemarituzumab |
| D000096662 | Ramucirumab |
| D000077594 | Nivolumab |
| 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
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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