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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-JE-BT22 |
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To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Cisplatin | Experimental | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
|
| Gemcitabine | Experimental | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 1000 milligrams per square meter (mg/m2), intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Alive at 1 Year (1-Year Survival Rate) | Percentage of patients alive at 1 year. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Response Evaluation Criteria In Solid Tumors - define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Time | Data of patients lost to follow-up were censored at the last date of confirmation of their survival. | baseline to date of death due to any cause (up to 2 years) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | 466-8560 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine + Cisplatin | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
| FG001 | Gemcitabine | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine + Cisplatin | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Percentage of Patients Alive at 1 Year (1-Year Survival Rate) | Percentage of patients alive at 1 year. | Number of patients who received at least one dose of study drug. | Posted | Number | percentage of participants | 1 year |
|
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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 | Gemcitabine + Cisplatin | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| cisplatin | Drug | 25 milligrams per square meter (mg/m2), intravenous (IV) |
|
| baseline to measured progressive disease (up to 2 years) |
| Progression Free Survival | The period from study entry until disease progression, death or date of last contact. | baseline to measured progressive disease (up to 2 years) |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | 277-8577 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukuoka | 811-1395 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hokkaido | 060-8648 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 241-0815 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shizuoka | 411-8777 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 104-0045 | Japan |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG001 | Gemcitabine | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
|
| Primary Tumor | Number | participants |
|
| Tumor Histological Type | Number | participants |
|
| Body Surface Area | Mean | Standard Deviation | square meter (m^2) |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
|
|
| Secondary | Tumor Response | Response Evaluation Criteria In Solid Tumors - define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. | Number of patients who received at least one dose of study drug. | Posted | Number | participants | baseline to measured progressive disease (up to 2 years) |
|
|
|
|
| Secondary | Progression Free Survival | The period from study entry until disease progression, death or date of last contact. | Number of patients who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | baseline to measured progressive disease (up to 2 years) |
|
|
|
|
| Other Pre-specified | Survival Time | Data of patients lost to follow-up were censored at the last date of confirmation of their survival. | Posted | Median | 95% Confidence Interval | months | baseline to date of death due to any cause (up to 2 years) |
|
|
|
|
| 9 |
| 41 |
| 41 |
| 41 |
| EG001 | Gemcitabine | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. | 17 | 42 | 42 | 42 |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemobilia | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood cholesterol decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood cholinesterase decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bile duct stent insertion | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Catheter placement | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Angiopathy | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
| D004066 |
| Digestive System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Stable Disease |
|
| Progressive Disease |
|
| Not Evaluable |
|