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The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| imexon + gemcitabine | Experimental | imexon + gemcitabine |
|
| Placebo + gemcitabine | Active Comparator | Placebo in combination with gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imexon in combination with gemcitabine | Drug | 875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival for the Intent to Treat Population | To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment. | up to 2 years |
| To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events | Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events | Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rates of the Two Treatment Arms | Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response. | one year |
| Progression Free Survival |
Not provided
Inclusion Criteria:
Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
Age at least 18 years.
ECOG performance status 0 or 1.
No prior chemotherapy or radiation therapy.
Projected life expectancy at least 2 months.
If female, neither pregnant nor lactating.
If of child bearing potential must agree to, and be able to use adequate contraception.
Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
No other concurrent active malignancy.
No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
Laboratory values within the following criteria:
Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm^3 ANC greater than or equal 1,500/mm^3 Platelet count greater than or equal 100,000/mm^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)
G6PD level greater than or equal lower limit of normal (LLN).
Able to render informed consent and follow protocol requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Hersh, MD | AmpliMed Corporation | Study Director |
| Steven Cohen, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology and Oncology- US Oncology | Birmingham | Alabama | 35205 | United States | ||
| AZ Onc Associates D.B.A. Hematology Oncology- US Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26709865 | Background | Cohen SJ, Zalupski MM, Conkling P, Nugent F, Ma WW, Modiano M, Pascual R, Lee FC, Wong L, Hersh E. A Phase 2 Randomized, Double-Blind, Multicenter Trial of Imexon Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy-naive Pancreatic Adenocarcinoma. Am J Clin Oncol. 2018 Mar;41(3):230-235. doi: 10.1097/COC.0000000000000260. |
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Recruitment period was from April 2008 to May 2009. Enrollment occurred at 34 clinical centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amplimexon (Imexon) + Gemcitabine | Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2 |
| FG001 | Imexon Placebo + Gemcitabine | Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| imexon placebo + gemcitabine | Drug | imexon placebo IV + 1000 mg/m^2 gemcitabine IV |
|
|
To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
| one year |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | United States |
| Rocky Mountain Cancer Center- US Oncology | Denver | Colorado | 80218 | United States |
| Ocala Oncology Center- US Oncology | Ocala | Florida | 34471 | United States |
| Cancer Centers of Florida- US Oncology | Orlando | Florida | 34761 | United States |
| Peachtree Hematology and Oncology Consultants | Atlanta | Georgia | 30309 | United States |
| Hematology Oncology Associates of Illinois- US Oncology | Chicago | Illinois | 60611 | United States |
| Cancer Care & Hematolog Specialists of Chicagoland- US Oncology | Niles | Illinois | 60714 | United States |
| Central Indiana Cancer Centers- US Oncology | Indianapolis | Indiana | 46227 | United States |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | United States |
| Hope Center- US Oncology | Terre Haute | Indiana | 47802 | United States |
| University of Kentucky, Hematology/Oncology/BMT Clinical Research | Lexington | Kentucky | 40536-0093 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Kansas City Cancer Center, LLC- US Oncology | Kansas City | Missouri | 64131 | United States |
| Comprehensive Cancer Centers of Nevada- US Oncology | Las Vegas | Nevada | 89169 | United States |
| Hunterdon Regional Cancer Center | Flemington | New Jersey | 08822 | United States |
| Hematology Oncology Associates | Mount Holly | New Jersey | 08060 | United States |
| Hematology Oncology Associates | Albuquerque | New Mexico | 87106 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| University of New Mexico Cancer Center South | Las Cruces | New Mexico | 88011 | United States |
| New Mexico Cancer Care Associates- US Oncology | Santa Fe | New Mexico | 87505 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Cancer Center of North Carolina- US Oncology | Raleigh | North Carolina | 27607 | United States |
| Medical Onc Assoc of Wyoming Valley, PC- US Oncology | Kingston | Pennsylvania | 18704 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | United States |
| Pottstown Memorial Medical Center | Pottstown | Pennsylvania | 19464 | United States |
| Associates in Hematology-Oncology P.C. US Oncology | Upland | Pennsylvania | 19013 | United States |
| Reading Hospital Regional Medical Center | West Reading | Pennsylvania | 19611 | United States |
| Sanford Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Texas Oncology - Amarillo- US Oncology | Amarillo | Texas | 79106 | United States |
| Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology | Beaumont | Texas | 77702 | United States |
| Texas Oncology P.A.- Bedford- US Oncology | Bedford | Texas | 76022 | United States |
| Texas Cancer Center at Medical City- US Oncology | Dallas | Texas | 75230 | United States |
| Texas Oncology P.A. - Dallas- US Oncology | Dallas | Texas | 75231 | United States |
| Methodist Charlton Cancer Center - Texas Oncology- US Oncology | Dallas | Texas | 75237 | United States |
| Texas Oncology - Odessa- US Oncology | Odessa | Texas | 79761 | United States |
| Scott and White Hospital and Clinics | Temple | Texas | 76508 | United States |
| Texas Oncology Cancer Care and Research Center- US Oncology | Waco | Texas | 76712 | United States |
| Texoma Cancer Center- US Oncology | Wichita Falls | Texas | 76310 | United States |
| Virginia Oncology Associates- US Oncology | Norfolk | Virginia | 23502 | United States |
| Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology | Salem | Virginia | 24153 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Cancer Care Northwest- US Oncology | Spokane | Washington | 99202 | United States |
| Northwest Cancer Specialists- US Oncology | Vancouver | Washington | 98684 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Amplimexon (Imexon) + Gemcitabine | Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2 |
| BG001 | Imexon Placebo + Gemcitabine | Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2 |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | 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 for the Intent to Treat Population | To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment. | Intention to treat with subjects who were alive at the time of the survival analysis or lost to follow-up were considered censored at the last date the subject was known to be alive. | Posted | Median | 95% Confidence Interval | months | up to 2 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events | Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events | This includes only those subjects that received at least 1 dose of study treatment. There were 67 subjects in the imexon + gemcitabine arm and 68 in the placebo + gemcitabine arm. | Posted | Number | participants | Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rates of the Two Treatment Arms | Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response. | Per protocol, response evaluable population was treated and had baseline and at least one response evaluation. | Posted | Number | percent of responses | one year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria. | Intention to treat | Posted | Median | 95% Confidence Interval | months | one year |
|
|
Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
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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 | Amplimexon (Imexon) + Gemcitabine | Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2 | 51 | 67 | 66 | 67 | ||
| EG001 | Imexon Placebo + Gemcitabine | Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2 | 44 | 68 | 68 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin (low) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils (low) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Conduction abnormality-AV block-third degree | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular arrhythmia-atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular arrhythmia-atrial flutter | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Left ventricular diastolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death-death not otherwise specified | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death-disease progression not otherwise specified | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal (GI) other-gastrostromy (G) tube leak | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction-small bowel not otherwise specified | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stricture-biliary tree | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-abdomen not otherwise specified | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-duodenum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage- lower gastrointestinal not otherwise specified | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-other gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-upper gastrointestinal not otherwise specified | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hepatobiliary-other-biliary obstruction | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver dysfunction | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever-neutropenic | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal absolute neutrophil count-biliary tree | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal absolute neutrophil count-blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal absolute neutrophil count-lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal absolute neutrophil count-cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown absolute neutrophil count-lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Edema:trunk/genital | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness-whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Central nervous system ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-abdomen not otherwise specified | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-chest/thorax not otherwise specified | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-pain not otherwise specified | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal-other-hemolytic uremic syndrome | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral arterial ischemia | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelets (low) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin (low) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils (low) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (low) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-abdomen not otherwise specified | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT (high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST (high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema:limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase (high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
The manuscript or abstract shall be submitted at least (45) days prior to submission for publication to permit Sponsor to request removal of any Confidential Information and to protect its rights to any patentable inventions set forth therein. Upon Sponsor's reasonable request, the investigator shall redact Sponsor's Confidential Information from any such proposed publication or shall delay publication for up to 90 days to permit Sponsor to protect its proprietary Information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Dorr | AmpliMed Corporation | 520-626-7892 | bdorr@azcc.arizona.edu |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C014919 | 4-imino-1,3-diazabicyclo(3.1.0)hexan-2-one |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|