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Due to Sponsor's decision, only 12 patients were randomized & completed study.
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This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following intratumoral administration of BC-819 and intravenously administered gemcitabine. Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS).
Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival.
Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on:
Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life, Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival
BC-819 (also known as DTA-H19) is a double-stranded DNA plasmid, 4,560 base pairs (bp) in length, carrying the gene for the Diphtheria toxin A (DT-A) chain under the regulation of the H19 promoter. This is a Targeted Cancer Therapy; DT-A chain expression is triggered by the presence of H19 transcription factors that are only up-regulated in tumor cells. The selective initiation of toxin expression results in selective tumor cell destruction via inhibition of protein synthesis selectively in the tumor cell, enabling highly targeted cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 mg BC-819 and Gemcitabine | Experimental | gemcitabine dose of 1000mg/m2 + 8 mg of BC-819 |
|
| 12 mg BC-819 and Gemcitabine | Experimental | gemcitabine dose of 1000mg/m2 + 12 mg of BC-819 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological/Vaccine: BC-819 | Biological | Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of BC-819 (8 mg or 12 mg according to allocations by randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | To compare the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival. PFS was defined as the time from the date of consent until objective tumor progression or death. Median PFS by Kaplan-Meier analysis was used for evaluation. The target tumor lesion was identified and the longest diameter of the target lesion was measured according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. For disease evaluations after treatment, scans conducted at baseline that were used for tumor measurements were repeated. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was calculated from the date of consent until death due to any cause. | 24 months |
| Response Rate of Target Lesion | Response rate will be assessed both for the primary target tumor lesion alone and overall, including development of metastases. Target tumor lesions are identified and the longest diameter of the target lesion is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. Complete response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also show an increase of at least 5 mm. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
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Inclusion Criteria:
Males or females > 18 years of age
If female, must not be pregnant or nursing; women of child-bearing potential must practice a medically approved method of contraception
If male, must practice a medically approved method of contraception if have a partner of childbearing potential
Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
Locally advanced pancreatic cancer (LAPC) that is clinically unresectable as defined in the NCCN Guidelines
Karnofsky performance status (KPS) ≥ 70% at baseline
Adequate hematological, renal, and hepatic function
Have a target tumor lesion in the pancreas ≤ 6 cm in diameter that is accessible for intratumoral administration by EUS guidance as determined by the physician performing the EUS injection
Have a biopsy specimen that is positive for H19 expression (grade 2 or greater staining determined by a pathologist). H19 expression can be determined based on a biopsy specimen collected before study participation, if available.
No prior diagnosis of malignancy within 3 years except for curatively treated non-melanoma skin or in situ malignancies
Able to comply with the protocol procedures
Able and willing to provide written (signed) Informed Consent to participate in the study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States | ||
| Thomas Jefferson University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 8 mg BC-819 and Gemcitabine | gemcitabine dose of 1000mg/m2 + 8 mg of BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
|
| 8 weeks |
| Resectability of the Target Tumor Lesion | Resectability of the target tumor lesion was determined by CT/MRI as defined in the National Comprehensive Cancer network (NCCN) guidelines. Resectable tumors have no arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic artery [CHA]) and no tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or ≤180° contact without vein contour irregularity. *Not Applicable refers to another clinically significant abnormality that interfered with resectability determination of the target tumor lesion. | an average of 16 weeks |
| Quality of Life (QoL) Assessed by Karnofsky Performance Status (KPS) | Quality of life will be assessed by the The Karnofsky Performance Status (KPS) Index. KPS scores over time will be compared to those at baseline and changes from baseline will be presented. KPS scores are on a scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100) of 0 (dead) to 100 (Normal no complaints; no evidence of disease). | Screening, Visit 4 (post gemcitabine induction), Visit 9 (5 weeks), Visit 13 (9 weeks) |
| Quality of Life Using the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire | The FACT-G is a 27-item compilation of general questions divided into 4 primary QoL domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The total FACT-G scores will be summarized by descriptive statistics (e.g., n, mean, median, standard deviation and range). The individual FACT-G score will be presented by frequency and percentage. Scores range from 0-108. High total scores represent better general QoL. | Screening, Visit 4 (post gemcitabine induction), Visit 9 (5 weeks), Visit 13 (9 weeks), every 6 months after Visit 13 |
| Serological Tumor Marker: CA 19-9 | Serum was collected for quantitative measurement of CA 19-9. | 24 months |
| Extent of Exposure - Gemcitabine Total Exposure (g) | Measured by the average and median number of exposure of the patients to BC-819 and gemcitabine. | 24 months |
| Extent of Exposure - Gemcitabine Total Number of Treatments | Measured by the average and median number of treatments of the patients to BC-819 and gemcitabine. | 24 months |
| Extent of Exposure - BC-819 Total Exposure (mg) | Measured by the average and median exposure of the patients to BC-819 and gemcitabine. | 24 months |
| Extent of Exposure - BC-819 Total Number of Treatments | Measured by the average and median number of treatments of the patients to BC-819 and gemcitabine. | 24 months |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | United States |
| Carmel Medical Center | Haifa | Israel |
| Rambam Medical Center | Haifa | Israel |
| Hadassah Medical Organization | Jerusalem | Israel |
| Meir Medical Center | Kfar Saba | Israel |
| Galil Maaravi | Nahariya | Israel |
| Tel Aviv Medical Center | Tel Aviv | Israel |
| FG001 | 12 mg BC-819 and Gemcitabine | gemcitabine dose of 1000mg/m2 + 12 mg of BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 8 mg BC-819 and Gemcitabine | gemcitabine dose of 1000mg/m2 + 8 mg of BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819 |
| BG001 | 12 mg BC-819 and Gemcitabine | gemcitabine dose of 1000mg/m2 + 12 mg of BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Progression-free Survival (PFS) | To compare the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival. PFS was defined as the time from the date of consent until objective tumor progression or death. Median PFS by Kaplan-Meier analysis was used for evaluation. The target tumor lesion was identified and the longest diameter of the target lesion was measured according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. For disease evaluations after treatment, scans conducted at baseline that were used for tumor measurements were repeated. | ITT comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was calculated from the date of consent until death due to any cause. | ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Median | 95% Confidence Interval | years | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response Rate of Target Lesion | Response rate will be assessed both for the primary target tumor lesion alone and overall, including development of metastases. Target tumor lesions are identified and the longest diameter of the target lesion is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. Complete response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also show an increase of at least 5 mm. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | ITT population comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Count of Participants | Participants | 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Resectability of the Target Tumor Lesion | Resectability of the target tumor lesion was determined by CT/MRI as defined in the National Comprehensive Cancer network (NCCN) guidelines. Resectable tumors have no arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic artery [CHA]) and no tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or ≤180° contact without vein contour irregularity. *Not Applicable refers to another clinically significant abnormality that interfered with resectability determination of the target tumor lesion. | ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population. | Posted | Count of Participants | Participants | an average of 16 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (QoL) Assessed by Karnofsky Performance Status (KPS) | Quality of life will be assessed by the The Karnofsky Performance Status (KPS) Index. KPS scores over time will be compared to those at baseline and changes from baseline will be presented. KPS scores are on a scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100) of 0 (dead) to 100 (Normal no complaints; no evidence of disease). | ITT population comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Median | Full Range | score on a scale | Screening, Visit 4 (post gemcitabine induction), Visit 9 (5 weeks), Visit 13 (9 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life Using the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire | The FACT-G is a 27-item compilation of general questions divided into 4 primary QoL domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The total FACT-G scores will be summarized by descriptive statistics (e.g., n, mean, median, standard deviation and range). The individual FACT-G score will be presented by frequency and percentage. Scores range from 0-108. High total scores represent better general QoL. | ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Mean | Standard Deviation | units on a scale | Screening, Visit 4 (post gemcitabine induction), Visit 9 (5 weeks), Visit 13 (9 weeks), every 6 months after Visit 13 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serological Tumor Marker: CA 19-9 | Serum was collected for quantitative measurement of CA 19-9. | ITT population comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Mean | Standard Deviation | U/mL | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Extent of Exposure - Gemcitabine Total Exposure (g) | Measured by the average and median number of exposure of the patients to BC-819 and gemcitabine. | ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Mean | Standard Deviation | g | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Extent of Exposure - Gemcitabine Total Number of Treatments | Measured by the average and median number of treatments of the patients to BC-819 and gemcitabine. | ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Mean | Standard Deviation | number of treatments | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Extent of Exposure - BC-819 Total Exposure (mg) | Measured by the average and median exposure of the patients to BC-819 and gemcitabine. | ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Mean | Standard Deviation | mg | 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Extent of Exposure - BC-819 Total Number of Treatments | Measured by the average and median number of treatments of the patients to BC-819 and gemcitabine. | ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population | Posted | Mean | Standard Deviation | number of treatments | 24 months |
|
24 months
Adverse Events were only assessed after randomization to either dose level of BC-819.
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 | 8 mg BC-819 and Gemcitabine | gemcitabine dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 8 mg BC-819 | 0 | 6 | 5 | 6 | 5 | 6 |
| EG001 | 12 mg BC-819 and Gemcitabine | gemcitabine dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819 | 1 | 6 | 5 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Generalized Edema | General disorders | MedDRA (14.0) | Systematic Assessment | Subjects with SAEs related to gemcitabine with reasonable possibility |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Epigastric pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment | Reasonable possibility of relationship to study procedure. |
|
| Frequent bowel movement | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment | One subject who reported this SAE had a reasonable possibility of relationship to study procedure |
|
| Duodenitis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Stent malfunction | Product Issues | MedDRA (14.0) | Systematic Assessment | Reasonable possibility of relationship to study procedure. |
|
| Melena | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bilateral pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Injection site abscess | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment | Reasonable possibility of relationship to study procedure. |
|
| Blood bilirubin increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Peripheral edema | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Increased blood bilirubin | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Increased gamma glatamyl transferase | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased neutrophil count | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Increased alanine aminotransferase | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Increased aspartate aminotransferase | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Increased blood alkaline phosphatase | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased haemoglobin | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Abnormal liver function tests | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased platelet count | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased weight | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to BC-819 with reasonable possibility |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Constipation | Gastrointestinal disorders | medDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Diahrrea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Peripheral edema | General disorders | medDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Cellulitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Abnormal liver function test | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Decreased platelet count | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Decreased weight | Investigations | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment | Subjects with AEs Related to gemcitabine with reasonable possibility |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Kerstein | Anchiano Therapeutics Israel Ltd. | 857-259-4626 | david.kerstein@anchiano.com |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
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| OG001 | 12 mg BC-819 and Gemcitabine | gemcitabine dose of 1000mg/m2 + 12 mg of BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819 |
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gemcitabine dose of 1000mg/m2 + 12 mg of BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819 |
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gemcitabine dose of 1000mg/m2 + 12 mg of BC-819 Biological/Vaccine: BC-819: Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression. After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of 12 mg BC-819 |
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