Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FG-3019 + Gemcitabine + Nab-paclitaxel | Experimental | Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles. |
|
| Gemcitabine + Nab-paclitaxel | Active Comparator | Participants will receive gemcitabine 1000 mg/ meter squared (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FG-3019 | Drug | FG-3019 will be administered per dose and schedule specified in the arm group description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196) |
| Number of Participants Who Had Surgical Complications Post-Resection | Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported | 30 days following discharge after surgery (up to Day 198) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Became Eligible for Surgery | After completion of 24 weeks of treatment with study drug | |
| Number of Participants in Whom R0 Resection Was Achieved | R0 resection was determined by pathological examination of the surgical specimen after resection. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vincent Picozzi, MD | Virginia Mason Medical Center - Benaroya Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of California, Los Angeles |
Not provided
| Label | URL |
|---|---|
| Link to sponsor website where additional information is available regarding the investigational product and ongoing clinical trials. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) | Participants received gemcitabine at 1000 milligrams (mg)/ meters (m)^2 plus nab-paclitaxel at 125 mg/m^2 by intraveneous (IV) infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kilograms (kg) by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment. |
| 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 | Yes | No | No | Study Protocol | Sep 29, 2016 | Dec 14, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine | Drug | Gemcitabine will be administered per dose and schedule specified in the arm group description. |
|
|
| Nab-paclitaxel | Drug | Nab-paclitaxel will be administered per dose and schedule specified in the arm group description. |
|
|
| After completion of 24 weeks of treatment with study drug |
| Number of Participants in Whom R0 or R1 Resection Was Achieved | R0 or R1 resection was determined by pathological examination of the surgical specimen after resection. | After completion of 24 weeks of treatment with study drug |
| Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization up to Week 52 |
| Median Overall Survival | Overall survival was defined as the time from randomization until death from any cause. | From randomization until death from any cause, assessed up to 4 years |
| Median Progression-Free Survival | Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From randomization until objective tumor progression or death, assessed up to 4 years |
| Los Angeles |
| California |
| 90095 |
| United States |
| Georgetown University - Medstar Health Research Institute | Washington D.C. | District of Columbia | 20007 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55404 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Virginia Mason Medical Center - Benaroya Research Institute | Seattle | Washington | 98101 | United States |
| FG001 | Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) | Participants received gemcitabine at 1000 mg/ m^2 plus nab-paclitaxel at 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) | Participants received gemcitabine at 1000 mg/m^2 plus nab-paclitaxel at 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment. |
| BG001 | Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) | Participants received gemcitabine at 1000 mg/ m^2 plus nab-paclitaxel at 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | Safety population included all participants who had received any dose of study drug. | Posted | Count of Participants | Participants | From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Had Surgical Complications Post-Resection | Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported | ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel. | Posted | Count of Participants | Participants | 30 days following discharge after surgery (up to Day 198) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Became Eligible for Surgery | ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel. | Posted | Count of Participants | Participants | After completion of 24 weeks of treatment with study drug |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants in Whom R0 Resection Was Achieved | R0 resection was determined by pathological examination of the surgical specimen after resection. | ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel. | Posted | Count of Participants | Participants | After completion of 24 weeks of treatment with study drug |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants in Whom R0 or R1 Resection Was Achieved | R0 or R1 resection was determined by pathological examination of the surgical specimen after resection. | ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel. | Posted | Count of Participants | Participants | After completion of 24 weeks of treatment with study drug |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel. | Posted | Count of Participants | Participants | From randomization up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Median Overall Survival | Overall survival was defined as the time from randomization until death from any cause. | ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel. | Posted | Median | 95% Confidence Interval | months | From randomization until death from any cause, assessed up to 4 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Progression-Free Survival | Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | ITT population included all randomized participants who received any amount of study drugs including pamrevlumab, or gemcitabine, or nab-paclitaxel. | Posted | Median | 95% Confidence Interval | months | From randomization until objective tumor progression or death, assessed up to 4 years |
|
Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years.
Safety population included all participants who had received any dose of study drug.
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 | Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) | Participants received gemcitabine at 1000 mg/m^2 plus nab-paclitaxel at 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment. | 17 | 24 | 9 | 24 | 24 | 24 |
| EG001 | Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) | Participants received gemcitabine at 1000 mg/ m^2 plus nab-paclitaxel at 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment. | 7 | 13 | 6 | 13 | 12 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Lymphadenopthy | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Device occlusions | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatic insufficiency | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information Desk | FibroGen, Inc. | 415-978-1441 | FG3019-069Study@fibrogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2018 | Dec 14, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C560078 | pamrevlumab |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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 |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
| Participants |
|
|
|
|
| Participants |
|
|
|
|