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| Name | Class |
|---|---|
| Bankhead-Coley Florida Biomedical Research Program | UNKNOWN |
| James and Esther King Biomedical Research Program | OTHER |
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The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and after the vaccine treatment.
The vaccine will be made by mixing two kinds of cells: 1) some lung cancer cells, which have been grown in the lab, and 2) experimental "bystander (present but not taking part in the immune response)" cells. All the cells in the vaccine will be treated with high-dose X-rays to make sure that none of them grow and cause more cancer. The bystander cells are human cells that have been genetically changed to express GM-CSF and CD40L. These are called "GM.CD40L". (That is the original cells, called K562, with the genes for human GM-CSF and CD40L inserted into them). These changes are designed to help boost the participants' immune system to better fight the cancer in their body. GM-CSF is a hormone that is known to stimulate bone marrow to make more white blood cells.
CCL21 is a chemokine (protein) that helps to recruit T cells (a type of white blood cell that helps to protect the body from infections) and leads to hyper-responsive T cells. This leads to heightened immune responses when T cells are exposed to both CCL21 and antigen (a substance that when introduced into the body lead to production of an antibody)-presenting cells (A cell that can "present" antigen in a form that T cells can recognize it ). The induction of a strong cell-mediated immune response is the type of immunity expected to be most involved in controlling cancer cell growth. A randomized trial of a vaccine consisting of the GM.CD40L bystander cells and an equivalent number of allogeneic (taken from different individuals) tumor cells plus or minus CCL21 is proposed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Vaccinations | Experimental | Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period. |
|
| Phase II Arm A Vaccinations | Active Comparator | Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. |
|
| Phase II Arm B Vaccinations | Active Comparator | Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase I - GM.CD40L.CCL21 Vaccinations | Biological | This is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. Phase I: Participants receive the GM.CD40L.CCL21 vaccine in a standard 3+3 design. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Recommend Phase II Dose (RPDII) | Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component. | Up to 6 Months |
| Phase II: Progression Free Survival (PFS) | PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. | Up to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response according to Response Evaluation in Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; No new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. Progressive Disease (PD): 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration; All target measurable lesions must be assessed using the same techniques as baseline. |
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Inclusion Criteria:
Histologically confirmed metastatic adenocarcinoma of the lung
Patients must have received and completed first line therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
No external beam radiation therapy within 2 weeks of first vaccine administration
No stereotactic radiation therapy within 3 days of first vaccine
No targeted therapy within 2 weeks of first vaccine administration
No immunomodulatory therapy within 2 weeks of first vaccine administration
No chemotherapy within 4 weeks of first vaccine administration
During Screening period, no steroid therapy within 4 weeks of first vaccine administration
Patient's written informed consent
Adequate organ function (measured within a week of beginning treatment):
Patients will be tested for HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion.
Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm. With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jhanelle Gray, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
Three participants were enrolled in the Phase I portion of the study, followed by seventy participants enrolled in the Randomized Phase II portion of the study.
Participants were enrolled at Moffitt Cancer Center between April 2012 and June 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I GM.CD40L.CCL21 Vaccinations | Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period. |
| FG001 | Phase II Arm A GM.CD40L Cells Vaccinations | Phase II Arm A: Participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. |
| FG002 | Phase II Arm B GM.CD40L.CCL21 Vaccinations | Phase II Arm B: Participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I Vaccinations | Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. |
| BG001 | Phase II Arm A Vaccinations |
| 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 |
| 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 | Phase I: Recommend Phase II Dose (RPDII) | Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component. | All Phase I Participants | Posted | Number | Recommend Phase II Dose Level | Up to 6 Months |
|
3 years, 8 months
All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
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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 | Phase I GM.CD40L.CCL21 Vaccinations | Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | CTCAE v4.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jhanelle Gray | H. Lee Moffitt Cancer Center and Research Institute | 813-745-3050 | jhanelle.gray@moffitt.org |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018925 | Chemokines |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
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|
|
| Phase II - GM.CD40L cells Vaccinations | Biological | Patients randomized to Arm A will receive vaccinations on 3 occasions, at 2 week intervals. 7.5 X 10^6 irradiated H1944 tumor cells, 7.5 X 10^6 irradiated H2122 cells, and containing 15 X 10^6 GM.CD40L cells (1.1 mL) will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2 weeks after vaccine 3. If patients show no sign of disease progression, patients will then be vaccinated at 4-week intervals. |
|
|
| Phase II - GM.CD40L.CCL21 Vaccinations | Biological | This is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. Phase II: Participants are randomized to one of the 2 arms (ratio 1:1): GM.CD40L versus GM.CD40L.CCL21. Patients in Arm B will receive vaccines at the same dose and schedule as described for patients in Arm A. In addition, their vaccine will include H1944 cells expressing CCL21. Note for patients on Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period. |
|
|
| Up to 12 Months |
| Death |
|
Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
| BG002 | Phase II Arm B Vaccinations | Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 | Phase I GM.CD40L.CCL21 Vaccinations | Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. |
|
|
| Primary | Phase II: Progression Free Survival (PFS) | PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. | A Phase II participants evaluable at time of analysis. | Posted | Median | 95% Confidence Interval | months | Up to 6 Months |
|
|
|
| Secondary | Response Rate | Response according to Response Evaluation in Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; No new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. Progressive Disease (PD): 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration; All target measurable lesions must be assessed using the same techniques as baseline. | All Phase II participants | Posted | Count of Participants | Participants | Up to 12 Months |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase II Arm A GM.CD40L Vaccinations | Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. | 14 | 37 | 35 | 37 |
| EG002 | Phase II Arm B GM.CD40L.CCL21 Vaccinations | Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. | 7 | 33 | 33 | 33 |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Death NOS | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gallbladder infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| General disorders and administration site conditions - Other | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Localized edema | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Tooth development disorder | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Investigations - Other | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| INR increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Spleen disorder | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nervous system disorders - Other | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Infections and infestations - Other | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Bronchial infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Papulopustular rash | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Vascular disorders - Other | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Urine discoloration | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ear and labyrinth disorders - Other | Ear and labyrinth disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Premature menopause | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011506 | Proteins |
| D002630 | Chemotactic Factors |
| D001685 | Biological Factors |
| D018836 | Inflammation Mediators |
| Progressive Disease |
|
| Stable Disease |
|