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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
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This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with pancreatic cancer who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.
Treatment will be administered in two phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (PD) or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NANT Pancreatic Cancer Vaccine | Experimental | A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALT-803 | Biological | Recombinant human super agonist interleukin-15 (IL-15) complex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | 30 days after last dose, up to 2 years (up to 1 year in each treatment phase) or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate by RECIST Version 1.1 | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 211 days. | |
| Objective Response Rate by irRC |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity resulting from previous therapy.
Within 5 years prior to first dose of study treatment, any evidence of other active malignancies or brain metastasis except controlled basal cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, cervical); prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL); bulky (≥ 1.5 cm) disease with metastasis in the central hilar area of the chest and involving the pulmonary vasculature.
Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
History of organ transplant requiring immunosuppression.
History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
Requires whole blood transfusion to meet eligibility criteria.
Inadequate organ function, evidenced by the following laboratory results:
Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
Positive results of screening test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
Known hypersensitivity to any component of the study medication(s).
Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Concurrent participation in any interventional clinical trial.
Pregnant and nursing women.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chan Soon-Shiong Institute for Medicine | El Segundo | California | 90245 | United States |
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
Eligible participants could have gone through both induction and maintenance treatment on study.
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| ID | Title | Description |
|---|---|---|
| FG000 | NANT Pancreatic Cancer Vaccine | A combination of agents were administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 [E1-, E2b-]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 [CD16.158V, ER IL-2] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine Cyclophosphamide: 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum SBRT: Stereotactic Body Radiation Therapy |
| 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 | Feb 15, 2018 |
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| ETBX-011 | Biological | Ad5 [E1-, E2b-]-CEA |
|
| GI-4000 | Biological | Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins |
|
| haNK for infusion | Biological | NK-92 [CD16.158V, ER IL-2] |
|
| avelumab | Biological | Recombinant human anti-PD-L1 IgG1 monoclonal antibody |
|
| bevacizumab | Biological | Recombinant human anti-VEGF IgG1 monoclonal |
|
| Capecitabine | Drug | 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine |
|
| Cyclophosphamide | Drug | 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate |
|
| Fluorouracil | Drug | 5-fluoro-2,4 (1H,3H)-pyrimidinedione |
|
| Leucovorin | Drug | L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt |
|
| nab-Paclitaxel | Drug | Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin |
|
| lovaza | Drug | Omega-3-acid ethyl esters |
|
| Oxaliplatin | Drug | cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum |
|
| SBRT | Procedure | Stereotactic Body Radiation Therapy |
|
| Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days. |
| Progression Free Survival by RECIST Version 1.1. | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death |
| Progression Free Survival by irRC | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression or death |
| Overall Survival | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until death |
| Duration of Response (DOR) by RECIST Version 1.1 and irRC | DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy. | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days |
| Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days |
| Quality of Life by Patient Reported Outcomes (PRO) | PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale. | Up to 9 months |
| Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NANT Pancreatic Cancer Vaccine | A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 [E1-, E2b-]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 [CD16.158V, ER IL-2] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine Cyclophosphamide: 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum SBRT: Stereotactic Body Radiation Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Subjects with pancreatic cancer who have progressed on or after previous SoC chemotherapy | Count of Participants | 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 | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | Posted | Count of Participants | Participants | 30 days after last dose, up to 2 years (up to 1 year in each treatment phase) or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest. |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate by RECIST Version 1.1 | Posted | Count of Participants | Participants | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 211 days. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate by irRC | Posted | Count of Participants | Participants | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival by RECIST Version 1.1. | Posted | Median | 95% Confidence Interval | Months | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival by irRC | Posted | Median | 95% Confidence Interval | Months | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression or death |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | Months | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until death |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by RECIST Version 1.1 and irRC | DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy. | There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis. | Posted | Median | 95% Confidence Interval | Months | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | Posted | Count of Participants | Participants | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life by Patient Reported Outcomes (PRO) | PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale. | Not all participants had QOLs collected for analysis. | Posted | Median | Full Range | score on a scale | Up to 9 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. | Posted | Count of Participants | Participants | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days |
|
Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
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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 | NANT Pancreatic Cancer Vaccine | A combination of agents were administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 [E1-, E2b-]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 [CD16.158V, ER IL-2] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine Cyclophosphamide: 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum SBRT: Stereotactic Body Radiation Therapy | 6 | 6 | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Obstruction gastric | Gastrointestinal disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Abdominal abscess | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aphthous ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
| ||
| Obstruction gastric | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Injection site reaction | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Injection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Injection site swelling | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Influenza like illness | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Catheter site irritation | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Feeling abnormal | General disorders | Systematic Assessment |
| ||
| Injection site bruising | General disorders | Systematic Assessment |
| ||
| Injection site oedema | General disorders | Systematic Assessment |
| ||
| Injection site pruritus | General disorders | Systematic Assessment |
| ||
| Injection site warmth | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Cold sweat | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Labile blood pressure | Vascular disorders | Systematic Assessment |
| ||
| Varicose vein | Vascular disorders | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vulvovaginal injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Ear discomfort | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Diplopia | Eye disorders | Systematic Assessment |
| ||
| Bile duct obstruction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal abscess | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Bobby Reddy, Chief Medical Officer | ImmunityBio | 855-797-9277 | Bobby.Reddy@Immunitybio.com |
| Apr 3, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C582303 | ALT-803 |
| C000609138 | avelumab |
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D003520 | Cyclophosphamide |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C520255 | 130-nm albumin-bound paclitaxel |
| C405603 | Omacor |
| D000077150 | Oxaliplatin |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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