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The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.
The objective of the study was to assess the safety and efficacy of a combination therapy of EndoTAG-1 plus gemcitabine vs. gemcitabine monotherapy in patients with locally advanced and/or metastatic adenocarcinoma of the pancreas eligible for second-line therapy after failing first line therapy with FOLFIRINOX
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoTAG-1 and Gemcitabine | Experimental | EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. |
|
| Gemcitabine Monotherapy | Active Comparator | Gemcitabine 1000mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoTAG-1 | Drug | twice weekly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis. | From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis. | From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues. |
Inclusion Criteria:
Exclusion Criteria:
Cardiovascular disease, New York Heart Association (NYHA) III or IV
History of severe supraventricular or ventricular arrhythmia
History of coagulation or bleeding disorder
History of acute myocardial infarction within 6 months before randomization
History of congestive heart failure
Acute or chronic inflammation (autoimmune or infectious)
Significant active/unstable non-malignant disease likely to interfere with study assessments
Laboratory tests (hematology, chemistry) outside specified limits:
Clinically significant ascites
Any anti-tumor treatment (except FOLFIRINOX as the first-line therapy) for pancreatic adenocarcinoma before enrollment. Note: Patients who have undergone surgical interventions for pancreatic adenocarcinoma will be eligible.
Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
Major surgery < 4 weeks prior to enrollment
Pregnant or nursing
Investigational medicinal product < 4 weeks of enrollment
Documented HIV history
Active hepatitis B infection requiring acute therapy Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria.
Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations
History of malignancy other than pancreatic cancer < 3 years prior to enrollment, except nonmelanoma skin cancer or carcinoma in situ of the cervix treated locally
Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)
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| Name | Affiliation | Role |
|---|---|---|
| Li-Tzong Chen, M.D., Ph.D. | National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Compassionate Cancer Care Medical Group, Inc | Corona | California | 92879 | United States | ||
| Emory University Hospital |
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218 subjects were enrolled between October 2018 and July 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | EndoTAG-1 and Gemcitabine | EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. EndoTAG-1: twice weekly Gemcitabine: once weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2021 | Oct 26, 2022 |
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| Gemcitabine | Drug | once weekly |
|
|
| Percentage of Subjects With Objective Response | Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1. | Up to approximately 33.5 months (assessed continuously during treatment) |
| Duration of Response | Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30. | From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause. |
| Percentage of Subjects With Disease Control According to RECIST v.1.1 | Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1 | Up to approximately 33.5 months (assessed continuously during treatment) |
| Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments. | Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course) |
| Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) |
| Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score. | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| John B. Amos Cancer Center / IACT Health | Columbus | Georgia | 31904 | United States |
| Orchard Healthcare Research (OHR) Inc. | Skokie | Illinois | 60077 | United States |
| Investigator Clinical Research Centers of Indiana | Indianapolis | Indiana | 46260-2082 | United States |
| Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center) | Topeka | Kansas | 66606 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| North Mississippi Hematology & Oncology Associates, Ltd. | Tupelo | Mississippi | 38801 | United States |
| Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic | Lincoln | Nebraska | 68510 | United States |
| Guthrie - Corning Hospital - Guthrie Cancer Center | Sayre | Pennsylvania | 18840-1625 | United States |
| Charleston Cancer Center | North Charleston | South Carolina | 29406 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Scott & White Vasicek Cancer Treatment Center | Temple | Texas | 76508 | United States |
| Renovatioclinical | The Woodlands | Texas | 77380 | United States |
| University of Virginia Hospital | Charlottesville | Virginia | 22908 | United States |
| CHU Angers | Angers | France |
| CHRU - Besançon | Besançon | France |
| Hopital Haut Leveque | Bordeaux | France |
| CHRU Brest - Hôpital Morvan | Brest | France |
| Centre Hospitalier de Cholet | Cholet | France |
| Centre Georges François Leclerc | Dijon | France |
| Centre Hospitalier Départemental | La Roche-sur-Yon | France |
| Hôpital Privé Jean Mermoz | Lyon | France |
| La Timone | Marseille | France |
| Institut de Cancérologie de Lorraine | Nancy | France |
| Centre Antoine-Lacassagne | Nice | France |
| Hopital La Pitié Salpétrière | Paris | France |
| CH Saint Jean | Perpignan | 66046 | France |
| Centre Eugène Marquis | Rennes | France |
| Clinique Sainte Anne/Strasbourg Oncologie Leberale | Strasbourg | France |
| Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet | Budapest | Hungary |
| Magyar Honvédség Egészségügyi Központ | Budapest | Hungary |
| Országos Onkológiai Intézet | Budapest | Hungary |
| Bács-Kiskun Megyei Kórház Onkoradiológiai Központ | Kecskemét | Hungary |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház | Miskolc | Hungary |
| Pécsi Tudomány Egyetem Onkoterápiás Intézet | Pécs | Hungary |
| Oncology Department, Hillel Yafe MC | Hadera | Israel |
| Rambam Health Center | Haifa | Israel |
| Meir Medical Center | Kfar Saba | Israel |
| Rabin MC | Petah Tikva | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | Russia |
| Kursk State Clinical Oncology Dispensary | Kursk | Russia |
| Federal State Budgetary Scientific Institution "Russian Oncological Scientific Center named after N.N.Blokhin" | Moscow | Russia |
| Private clinnic "Medicine 24/7" | Moscow | Russia |
| Budget Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary" | Omsk | Russia |
| State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary" | Orenburg | Russia |
| State Budgetary Healthcare Institution Leningrad Regional Oncology Center | Saint Petersburg | Russia |
| Chungnam National University Hospital | Daejeon | South Korea |
| National Cancer Center | Goyang-si | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Chonnam National University Hwasun Hospital | Jeongnam | South Korea |
| CHA Bundang Medical Center | Seongnam | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Changhua Christian Hospital | Changhua | Taiwan |
| Chang Gung Medical Foundation - Kaohsiung Branch | Kaohsiung City | Taiwan |
| E-Da Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Mackay Memorial Hospital-Taipei Branch | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Tri-Service General Hospital (TSGH) | Taipei | Taiwan |
| Chang Gung Medical Foundation - Linkou Branch | Taoyuan | Taiwan |
| FG001 | Gemcitabine Monotherapy | Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. Gemcitabine: once weekly |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EndoTAG-1 and Gemcitabine | EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. EndoTAG-1: twice weekly Gemcitabine: once weekly |
| BG001 | Gemcitabine Monotherapy | Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. Gemcitabine: once weekly |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Extent of Disease at Randomization | Count of Participants | Participants |
| ||||||||||||||||||
| ECOG Performance at Randomization | ECOG 0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction. ECOG 1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). | 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 | Overall Survival | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis. | Posted | Median | 95% Confidence Interval | days | From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis. | Posted | Median | 95% Confidence Interval | days | From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Objective Response | Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1. | Of the 108 subjects that received EndoTAG-1 and Gemcitabine, 11 subjects (11.46%, 11/96) presented with a complete or partial response. There were 6 subjects (6.82%, 6/88) that received Gemcitabine Monotherapy considered to have an objective response. For 12 subjects in the EndoTAG-1 group and 22 subjects in the Gemcitabine Monotherapy group, objective response assessments were missing. | Posted | Count of Participants | Participants | Up to approximately 33.5 months (assessed continuously during treatment) |
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| Secondary | Duration of Response | Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30. | Posted | Mean | Standard Deviation | Months | From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause. |
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| Secondary | Percentage of Subjects With Disease Control According to RECIST v.1.1 | Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1 | There were 12 subjects in the EndoTAG-1 treated group and 22 subjects in the Gemcitabine Monotherapy group that were not included in analysis due to missing records. | Posted | Count of Participants | Participants | Up to approximately 33.5 months (assessed continuously during treatment) |
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| Secondary | Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments. | Posted | Count of Participants | Participants | Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course) |
|
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| Other Pre-specified | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues. | Some missing data (Change from baseline is based on subjects with paired values.) | Posted | Mean | Standard Deviation | score on a scale | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) |
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| Other Pre-specified | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score. | Some missing data (Change from baseline is based on subjects with paired values.) | Posted | Mean | Standard Deviation | score on a scale | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) |
|
Up to approximately 33.5 months (assessed continuously during treatment)
All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy.
Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EndoTAG-1 and Gemcitabine | EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. EndoTAG-1: twice weekly Gemcitabine: once weekly | 91 | 108 | 52 | 102 | 101 | 102 |
| EG001 | Gemcitabine Monotherapy | Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. Gemcitabine: once weekly | 85 | 110 | 48 | 102 | 100 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Colitis erosive | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Malignant biliary obstruction | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Thrombotic microangiopathy | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet Count Decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albert Lin, Ph.D./Special Assistant to GM | SynCore Biotechnology Co., Ltd. | +886-2-2760-3688 | 2308 | JWLin@syncorebio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2021 | Oct 26, 2022 | SAP_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 |
|---|---|
| C511389 | MBT-0206 |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hungary |
|
| United States |
|
| Taiwan |
|
| Israel |
|
| France |
|
| Russia |
|
| Locally Advanced |
|
| 1 |
|
| Participants |
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. Gemcitabine: once weekly |
|
|
Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. Gemcitabine: once weekly |
|
|