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Study was closed due to low subject enrollment at site.
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| Name | Class |
|---|---|
| Cantex Pharmaceuticals | INDUSTRY |
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This is an open-label Phase 2 Pilot study to evaluate Disulfiram + Copper Gluconate in patients metastatic pancreatic cancer whose CA-19-9 levels rise while receiving nab-paclitaxel (Abraxane) plus gemcitabine (Gemzar) or FOLFIRINOX or single-agent gemcitabine (Gemzar). Patient must have received a minimum of 8 weeks of treatment and have rising CA-19-9 levels in the absence of radiographic evidence of progression.
This study has 3 arms with 5 patients enrolled in each of the three arms. The three treatment arms are based upon whether the patient has previously received Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine without radiographic evidence of disease progression for a minimum of 8 weeks , based on the investigator's opinion, but with a rising Carbohydrate antigen 19-9 (CA 19-9) levels. Rising CA 19-9 is defined as an increased over baseline of > 20% in two consecutive time points within 8 days of each other. Study sites will provide all chemotherapy for patients participating in the study as a "standard of care". DSF/Cu (Disulfiram + Copper Gluconate) will be provided by the Sponsor and shipped from the Sponsor's central depot to the study sites. Sufficient amounts of DSF/Cu will be available at the study site prior to enrolling patients in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-Paclitaxel/Gemcitabine + DSF/Cu | Active Comparator | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. |
|
| FOLFIRINOX +DSF/Cu | Active Comparator | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. |
|
| Single-Agent Gemcitabine +DSF/Cu | Active Comparator | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety Laboratories | Diagnostic Test | Complete blood cell count (CBC) w Differential, comprehensive metabolic panel (CMP), Prothrombin time/international normalized ratio (PT/INR) Activated Partial Thromboplastin Time (aPTT), Urinalysis |
| Measure | Description | Time Frame |
|---|---|---|
| CA19-9 Plasma Level | Change in plasma CA19-9 level (at least 30%) from baseline | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Tumor Response | Complete response rate as defined by CT scan using RECIST 1.1 criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Partial Response |
| Measure | Description | Time Frame |
|---|---|---|
| Disulfiram/Copper Gluconate Serum Levels - Area Under the Curve (AUC) | Optional Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7 | Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7 |
Inclusion Criteria:
Patients must have histologically confirmed adenocarcinoma of the pancreas that is metastatic and for which potential curative measures, such as resection of an isolated metastasis, are not available. Patients with islet cell neoplasms are excluded.
Patient should currently be receiving a chemotherapy regimen comprising FOLFIRINOX or Abraxane-Gemcitabine or single-agent Gemcitabine as front-line treatment for metastatic disease. Patients who have had chemotherapy in the adjuvant or neoadjuvant setting are eligible.
Patients must have previously received a minimum of 8 weeks of therapy with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine without radiographic evidence of disease progression based on the investigator's opinion, but a rising CA 19-9 level, and still be undergoing treatment with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine. Increased CA 19-9 is defined as an increased over baseline of > 20% in two consecutive time points within 8 days of each other.
Patient has one or more metastatic tumors measurable by CT scan. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100,000/mm3 (100 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL.
Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0:
Patient has ECOG performance status from 0 to ≤ 1.
Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gayle Jameson, ACNP-BC | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85251 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nab-Paclitaxel/Gemcitabine + DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Apr 19, 2019 |
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|
| AE Assessment | Other | Assessment of Adverse Events (AE) |
|
| Physical Exam | Other | Physical Exam, Weight, Vital Signs, Eastern Cooperative Oncology Group (ECOG) Performance Status |
|
| Concomitant Medication Review | Other | Prior and Concomitant Medication Review |
|
| Tumor Imaging | Diagnostic Test | Tumor CT or MRI |
|
| nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate | Drug | nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
|
| FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate | Drug | FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing |
|
| Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate | Drug | Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
|
Partial response as defined by CT scan using RECIST 1.1 criteria |
| From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Stable Disease | Complete response as defined by CT scan using RECIST 1.1 criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall Response Rate | Overall response rate as defined by CT scan using RECIST 1.1 criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall Survival | The length of time from the start of treatment that patients are still alive | From date of enrollment until date of death assessed up to 100 months |
| Serum Albumin | Change in serum albumin level as a result of treatment | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Body Weight | Change in body weight as a result of treatment | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Muscle Area at the L3 Level - Optional | Change in muscle area at the L3 level using CT scan. Only is L3 is visualized with normally scheduled standard of care CT Scan | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Incidence of Toxicities | Physical exam and laboratory testing will be completed and toxicity grading assessed and documented using CTCAE version 4.0 | From date of enrollment until the date of follow-up, 30 days after last treatment |
| FG001 | FOLFIRINOX +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| FG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| COMPLETED |
|
| NOT COMPLETED |
|
Study was closed due to low subject enrollment at site.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nab-Paclitaxel/Gemcitabine + DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| BG001 | FOLFIRINOX +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| BG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| BG003 | 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 |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | 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 | CA19-9 Plasma Level | Change in plasma CA19-9 level (at least 30%) from baseline | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
|
| |||||||||||||||||||||||||
| Secondary | Complete Tumor Response | Complete response rate as defined by CT scan using RECIST 1.1 criteria | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Partial Response | Partial response as defined by CT scan using RECIST 1.1 criteria | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Stable Disease | Complete response as defined by CT scan using RECIST 1.1 criteria | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate | Overall response rate as defined by CT scan using RECIST 1.1 criteria | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | The length of time from the start of treatment that patients are still alive | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until date of death assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Serum Albumin | Change in serum albumin level as a result of treatment | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Body Weight | Change in body weight as a result of treatment | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Muscle Area at the L3 Level - Optional | Change in muscle area at the L3 level using CT scan. Only is L3 is visualized with normally scheduled standard of care CT Scan | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| ||||||||||||||||||||||||||
| Secondary | Incidence of Toxicities | Physical exam and laboratory testing will be completed and toxicity grading assessed and documented using CTCAE version 4.0 | One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease. | Posted | From date of enrollment until the date of follow-up, 30 days after last treatment |
| ||||||||||||||||||||||||||
| Other Pre-specified | Disulfiram/Copper Gluconate Serum Levels - Area Under the Curve (AUC) | Optional Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7 | Not Posted | Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7 | Participants |
6 Weeks
One patient was treated. This patient was on study for 6 weeks and ended trial participation due to progressive disease.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nab-Paclitaxel/Gemcitabine + DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing | 1 | 1 | 1 | 1 | 1 | 1 |
| EG001 | FOLFIRINOX +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Progressive Disease |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Flushing/Sweats | Nervous system disorders | Non-systematic Assessment |
| ||
| Muscle Cramp/Burning | Nervous system disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Slurred Speach | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayle Jameson, MSN, ACNP-BC, AOCN | HonorHealth | 480-323-1364 | clinicaltrials@honorhealth.com |
| Aug 14, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2019 | Aug 14, 2023 | ICF_001.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 |
|---|---|
| D012149 | Restraint, Physical |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| D002985 | Clinical Protocols |
| D004221 | Disulfiram |
| D005942 | Gluconates |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D004050 | Ditiocarb |
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004220 | Disulfides |
| D013440 | Sulfides |
| D013457 | Sulfur Compounds |
| D013400 | Sugar Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
Not provided
Not provided
| >=65 years |
|
| Title | Measurements |
|---|---|
|
| American Indian |
|
| Alaska Native |
|
| Native Hawaiian |
|
| Pacific Rim |
|
| Unknown |
|
| Not Reported |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
AE Assessment: Assessment of Adverse Events
Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status
Concomitant Medication Review: Prior and Concomitant Medication Review
Tumor Imaging: Tumor CT or MRI
nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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| FOLFIRINOX +DSF/Cu |
Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
| OG002 | Single-Agent Gemcitabine +DSF/Cu | Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression. Safety Laboratories: CBC w Differential, CMP, PT/INR, aPTT, Urinalysis AE Assessment: Assessment of Adverse Events Physical Exam: Physical Exam, Weight, Vital Signs, ECOG Performance Status Concomitant Medication Review: Prior and Concomitant Medication Review Tumor Imaging: Tumor CT or MRI nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing |
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