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| Name | Class |
|---|---|
| Translational Genomics Research Institute | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
| Lustgarten Foundation | OTHER |
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The purpose of this study is to find out if the study drugs nivolumab, albumin- bound paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective when combined to treat advanced pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | open label using combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete response (CR) rate as defined by CT scan using RECIST 1.1 criteria - disappearance of all target lesions and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. When a complete response is documented, a Positron emission tomography (PET) scan will be obtained to confirm. | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death. | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erkut Borazanci, MD | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Nurse Navigator | Scottsdale | Arizona | 85258 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | open label using combination therapy Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | open label using combination therapy Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Complete Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete response (CR) rate as defined by CT scan using RECIST 1.1 criteria - disappearance of all target lesions and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. When a complete response is documented, a Positron emission tomography (PET) scan will be obtained to confirm. | Not evaluable for overall response as subject did not have post baseline scans (n=3) | Posted | Count of Participants | Participants | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months |
|
84 months
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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 | Single Arm | open label using combination therapy Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erkut Borazanci, MD MS | HonorHealth Research Institute | 4803231350 | clinicaltrials@honorhealth.com |
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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 | Jul 15, 2020 | Oct 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2020 | Oct 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000068196 | Albumin-Bound Paclitaxel |
| C084656 | paricalcitol |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Albumin-bound paclitaxel | Drug | 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle |
|
|
| Paricalcitol | Drug | 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle |
|
|
| Cisplatin | Drug | 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle |
|
|
| Gemcitabine | Drug | 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle |
|
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Tolerability |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| KARNOFSKY PERFORMANCE STATUS | The Karnofsky Performance Scale Index allows patients to be graded and classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. The higher Karnofsky score on the scale (0 =unable to care for self, requires equivalent of institutional or hospital care, disease may be progressing; 100=able to carry on normal activity and to work, no special care needed), indicates Normal, no complaints in functional impairment. | Count of Participants | Participants |
|
| Prior Treatment | Number | participants |
|
| Primary Tumor Location | Number | participants |
|
| Cancer Antigen (CA) 19-9 at C1/D1 | Count of Participants | Participants |
|
| Tumor Markers CA125 or CEA at C1/D1 | CA19-9 Non-secreters | Count of Participants | Participants |
|
| Vitamin D, ng/mL | Median | Full Range | ng/mL |
|
open label using combination therapy Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle |
|
|
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death. | adverse events (grade ≥ 3) observed in the study related to study treatment | Posted | Count of Participants | Participants | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months |
|
|
|
| 1 |
| 35 |
| 14 |
| 35 |
| 35 |
| 35 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bladder infection | Infections and infestations | Systematic Assessment |
|
| colitis | Gastrointestinal disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| diarrhea | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
|
| joint effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| lung infection | Infections and infestations | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| sepsis | Infections and infestations | Systematic Assessment |
|
| sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| stroke | Nervous system disorders | Systematic Assessment |
|
| thromboembolic event | Vascular disorders | Systematic Assessment |
|
| upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| alanine aminotransferease increase | Investigations | Systematic Assessment |
|
| neutrophil count decreased | Investigations | Systematic Assessment |
|
| platelet count decreased | Investigations | Systematic Assessment |
|
| white blood cell decreased | Investigations | Systematic Assessment |
|
| diarrhea | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| vitamin d decreased | Metabolism and nutrition disorders | Systematic Assessment |
|
| peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| unspecified rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| neutropenia |
|
| peripheral sensory neuropathy |
|
| colitis |
|
| diarrhea |
|
| hypokalemia |
|
| unspecified rash |
|